Fragmin

Deep Vein Thrombosis (DVT), Angina, Unstable, Thrombosis + 14 more

Treatment

19 FDA approvals

20 Active Studies for Fragmin

What is Fragmin

Dalteparin

The Generic name of this drug

Treatment Summary

Dalteparin is a medication used to prevent blood clots, and it is made from porcine intestinal mucosa. It is part of the low molecular weight heparin (LMWH) family, which has a predictable response, higher absorption rate, and longer lasting effects than traditional heparin. Dalteparin is generally safe for pregnant women and is less effective at preventing clotting caused by factor IIa.

Fragmin

is the brand name

image of different drug pills on a surface

Fragmin Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Fragmin

Dalteparin

1994

19

Approved as Treatment by the FDA

Dalteparin, also known as Fragmin, is approved by the FDA for 19 uses including Venous Thromboembolism and Prophylaxis of Deep Vein Thrombosis .

Venous Thromboembolism

Prophylaxis of Deep Vein Thrombosis

Deep Vein Thrombosis

Cancer

Symptomatic Venous Thromboembolism

Clotting

Hemodialysis

Haemofiltration

General Surgery

Deep Vein Thrombosis (DVT)

Prophylaxis of Venous Thromboembolic Events

Deep Vein Thrombosis

Arthroplasty

Venous Thromboembolism

Thrombosis

prophylaxis of Clotting

Abdominal Surgeries

Acute Coryza

severe restricted mobility

Effectiveness

How Fragmin Affects Patients

Dalteparin works by binding to the protein antithrombin (ATIII) in the blood, which helps prevent clotting. Doctors use the anti-Xa activity of the plasma to decide how much of the drug should be given. People with a creatinine clearance of less than 20mL/min should not use this drug, and instead take unfractionated heparin. To make sure the drug is working, doctors can measure the anti-Xa activity, but will not need to measure the active partial thromboplastin time (aPTT).

How Fragmin works in the body

Dalteparin helps stop your blood from clotting, much like unfractionated heparin. However, dalteparin is more targeted, and only affects one aspect of the clotting process. This means that you don't need to monitor it as closely as you would with other anticoagulants, except to watch for signs of an overdose.

When to interrupt dosage

The measure of Fragmin depends upon the determined situation, including Haemofiltration, Prophylaxis of Venous Thromboembolic Events and General Surgery. The amount furthermore shifts as per the technique of conveyance (e.g. Subcutaneous or Solution - Intravenous; Subcutaneous) specified in the accompanying table.

Condition

Dosage

Administration

Cardiovascular Events

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Deep Vein Thrombosis

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Acute Coryza

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Abdominal Surgeries

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Deep Vein Thrombosis (DVT)

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Angina, Unstable

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Thrombosis

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

prophylaxis of Clotting

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Myocardial Infarction

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

prophylaxis of cardiovascular event

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Haemofiltration

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Arthroplasty

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Prophylaxis of Venous Thromboembolic Events

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

General Surgery

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Venous Thromboembolism

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Hemodialysis

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

severe restricted mobility

100000.0 [iU]/mL, , 10000.0 [iU]/mL, 125000.0 [iU]/mL, 150000.0 [iU]/mL, 180000.0 [iU]/mL, 25000.0 [iU]/mL, 50000.0 [iU]/mL, 75000.0 [iU]/mL, 10000.0 units/mL, 25000.0 units/mL, 2500.0 units/mL, 180000.0 units/mL, 35000.0 units/mL, 100000.0 units/mL, 50000.0 units/mL, 125000.0 units/mL, 165000.0 units/mL, 150000.0 units/mL, 75000.0 units/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Intravenous; Subcutaneous, Liquid, Liquid - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Solution - Parenteral, Parenteral

Warnings

Fragmin has seven prohibitions, so it should not be employed when experiencing any of the conditions present in the following table.

Fragmin Contraindications

Condition

Risk Level

Notes

Hemorrhage

Do Not Combine

history of thrombocytopenia caused by Heparin

Do Not Combine

history of thrombocytopenia with thrombosis caused by Heparin

Do Not Combine

neuraxial anesthesia

Do Not Combine

lumbar epidural anesthesia therapy

Do Not Combine

Pulse Frequency

Do Not Combine

neuraxial anesthesia

Do Not Combine

There are 20 known major drug interactions with Fragmin.

Common Fragmin Drug Interactions

Drug Name

Risk Level

Description

Albutrepenonacog alfa

Major

The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dalteparin.

Andexanet alfa

Major

The therapeutic efficacy of Andexanet alfa can be decreased when used in combination with Dalteparin.

Anti-inhibitor coagulant complex

Major

The therapeutic efficacy of Anti-inhibitor coagulant complex can be decreased when used in combination with Dalteparin.

Antihemophilic factor (recombinant), PEGylated

Major

The therapeutic efficacy of Antihemophilic factor (recombinant), PEGylated can be decreased when used in combination with Dalteparin.

Antihemophilic factor human

Major

The therapeutic efficacy of Antihemophilic factor human can be decreased when used in combination with Dalteparin.

Fragmin Toxicity & Overdose Risk

An overdose of heparin can lead to bleeding complications. Common side effects with extended use include bone thinning, low platelet count, and mild liver enzyme elevation. Uncommon reactions include severe allergic reactions, skin rashes and necrosis, internal bleeding, and swelling.

image of a doctor in a lab doing drug, clinical research

Fragmin Novel Uses: Which Conditions Have a Clinical Trial Featuring Fragmin?

119 active studies are currently exploring the potential of Fragmin to treat Deep Vein Thrombosis, General Surgery and prevent Clotting.

Condition

Clinical Trials

Trial Phases

Haemofiltration

0 Actively Recruiting

prophylaxis of cardiovascular event

0 Actively Recruiting

Arthroplasty

3 Actively Recruiting

Not Applicable

Abdominal Surgeries

1 Actively Recruiting

Not Applicable

General Surgery

2 Actively Recruiting

Not Applicable

prophylaxis of Clotting

0 Actively Recruiting

Cardiovascular Events

4 Actively Recruiting

Not Applicable

severe restricted mobility

0 Actively Recruiting

Angina, Unstable

2 Actively Recruiting

Not Applicable

Acute Coryza

0 Actively Recruiting

Thrombosis

0 Actively Recruiting

Deep Vein Thrombosis

10 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 4

Prophylaxis of Venous Thromboembolic Events

1 Actively Recruiting

Phase 1

Deep Vein Thrombosis (DVT)

32 Actively Recruiting

Phase 4, Not Applicable, Early Phase 1, Phase 3, Phase 2, Phase 1

Hemodialysis

13 Actively Recruiting

Not Applicable, Phase 2

Myocardial Infarction

0 Actively Recruiting

Venous Thromboembolism

0 Actively Recruiting

Fragmin Reviews: What are patients saying about Fragmin?

5

Patient Review

5/1/2012

Fragmin for Prevention of Recurrent Vein Thrombosis in Cancer

Fragmin has worked great for me and I haven't had any side effects or problems with it.

4.3

Patient Review

10/14/2009

Fragmin for Treatment to Prevent a Blood Clot in the Lung

I've been using Fragmin for 19 days to help with my ankle bone fracture and so far it's been going well. I haven't had any problems or negative reactions to the medication. As per my surgeon's instructions, I can't put any weight on the ankle until it heals a bit more which hopefully will be soon. He may recommend that I stop taking Fragmin when I see him next Tuesday but overall it's been a good experience.

3.7

Patient Review

10/23/2010

Fragmin for Blood Clot in a Deep Vein

Fragmin has been very effective in precenting blood clots and strokes. The injection can be painful at times, but it is a small price to pay for the peace of mind it brings.

3.3

Patient Review

11/14/2008

Fragmin for Blood Clot in a Deep Vein

I've been 27 since my motorcycle accident. I lost my left leg and severely damaged my right leg to the point where it's been in a cast for two months now. I've been getting regular shots of this medication, but recently noticed that my stomach is really bruised. Can I inject the medication into another area?
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about fragmin

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Fragmin the same as heparin?

"Fragmin is an anticoagulant that prevents ischemic complications in unstable angina and non-Q-wave myocardial infarction."

Answered by AI

What is the medication Fragmin used for?

"Dalteparin is a medication used to treat and prevent harmful blood clots. Harmful blood clots can lead to a stroke or heart attack, so by preventing them, dalteparin reduces the risk of these happening. The medication does this by lowering the activity of clotting proteins in the blood, which helps to keep the blood flowing smoothly."

Answered by AI

Does Fragmin dissolve blood clots?

"This medication is an anticoagulant, belonging to a class of medications designed to prevent blood clots from forming or growing. It does not dissolve existing blood clots."

Answered by AI

What are the side effects of Fragmin?

"The side effects of Fragmin are: easy bruising or bleeding, pain, redness, irritation, bruising, or swelling where the medicine is injected. Fragmin can cause bleeding if it has too strong of an effect on your clotting proteins."

Answered by AI

Clinical Trials for Fragmin

Image of Brigham and Women's Hospital in Boston, United States.

Rosuvastatin for Cancer-Associated Blood Clots

18+
All Sexes
Boston, MA

Patients with cancer are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage. The primary aim of the Statin Therapy to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who do not otherwise take statin therapy.

Phase 4
Waitlist Available

Brigham and Women's Hospital (+1 Sites)

Image of Vermont Health in Burlington, United States.

Clinical Program for VTE Prevention in Cancer

18+
All Sexes
Burlington, VT

assess effectiveness of a , compared with usual care, to assess The goal of this study is to learn if a modified clinical program can improve adherence to guideline recommendations for prevention of venous thromboembolism in ambulatory patients with cancer. The main question\[s\] it aims to answer are: Does the modified program improve number of ambulatory oncology patients starting systemic treatment getting VTE risk-assessment? Does the modified program improve the number of patients receiving appropriate preventative anticoagulation? Researchers will compare to usual care (no clinical program). Participant clinicians will be asked to * receive education about VTE prevention recommendations * carry out risk assessment, anticoagulation discussions, and document the results Participant patients will receive care from clinicians participating in the study as part of their cancer care.

Waitlist Available
Has No Placebo

Vermont Health

Karlyn Martin, MD

Image of St.Joseph's Healthcare Hamilton in Hamilton, Canada.

Rivaroxaban + ASA for Hip Fracture

18+
All Sexes
Hamilton, Canada

A third of patients undergoing surgery for a hip fracture develop a myocardial injury (i.e., an elevated troponin measurement), and these patients are at substantial risk of death and morbidity. Current prophylaxis strategies focus on preventing venous thromboembolism (VTE); however, arterial events are more common and carry a poor prognosis. The association of acetylsalicylic acid (ASA) 75-100 mg once daily and rivaroxaban 2.5 mg twice a day (the regimen used in the COMPASS trial) might prevent both VTE and arterial cardiovascular events. Among patients who have undergone hip fracture surgery and have evidence of myocardial injury, to explore the feasibility of a randomized controlled trial (RCT) comparing rivaroxaban 2.5 mg twice daily + low-dose ASA (75-100 mg) for 90 days, with standard VTE thromboprophylaxis for 30 days, for prevention of major cardiovascular events. The HIPSTER-Pilot is a multicenter, international, open-label, pilot RCT with blinded outcome adjudication. A total of 100 participants aged ≥45 years who received hip fracture surgery and experienced a myocardial injury will be randomized to receive either rivaroxaban 2.5 mg twice daily plus ASA 75-100 mg daily for 90 days or standard VTE prophylaxis with an anticoagulant for 30 days. The primary feasibility outcome will be the recruitment rate. Other feasibility measures include completeness of follow-up and adherence to the treatment. Exploratory clinical outcomes will be assessed. This pilot trial will provide information on the feasibility of conducting a larger RCT to evaluate the efficacy and safety of the COMPASS regimen for preventing arterial and venous thrombotic events after hip fracture surgery in patients who have had myocardial injury. The results of this feasibility study will inform the design of the full-scale trial.

Phase 3
Waitlist Available

St.Joseph's Healthcare Hamilton (+1 Sites)

Federico Germini, Doctor of Medicine

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Image of Denver Metro Orthopedics, P.C. Englewood Location in Englewood, United States.

REGN7508 for Venous Thromboembolism

18+
All Sexes
Englewood, CO

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Phase 3
Recruiting

Denver Metro Orthopedics, P.C. Englewood Location (+10 Sites)

Clinical Trial Management

Regeneron Pharmaceuticals

Image of University of Vermont Medical Center in Burlington, United States.

Apixaban for Cancer

18+
All Sexes
Burlington, VT

Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience. This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots. The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups: Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose) Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose) Group 3: No anticoagulant (standard care) Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period. By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk. This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.

Phase 3
Waitlist Available

University of Vermont Medical Center

Image of Tampa General Hospital in Tampa, United States.

Fasting for Myocardial Infarction

18+
All Sexes
Tampa, FL

The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications. The study will answer: * Does eating and drinking before the procedure improve patient comfort? * Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc? Participants will be randomly assigned to either: * A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or * A no-fasting group (able to eat and drink as usual). Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.

Recruiting
Has No Placebo

Tampa General Hospital

Samip Vasaiwala, MD

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Wearable Ultrafiltration Device for Kidney Failure

18+
All Sexes
London, Canada

Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged. Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse). Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time. Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session. If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.

Waitlist Available
Has No Placebo

London Health Sciences Centre

Dr. Christopher McIntyre, MBBS DM

Image of DCI Desert Dialysis in Tucson, United States.

"Move More" Exercise Program for Hemodialysis Patients

18+
All Sexes
Tucson, AZ

The goal of this clinical trial is to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in hemodialysis (HD) patients. Exercise programs often fail to yield robust benefits for many HD patients, in part because the type and volume of exercise prescribed is inappropriate for a variety of reasons, and the benefits from these studies are often disappointing, as they are characterized by poor adherence, high dropout rates, and modest effects on physical function, body composition, cardiovascular disease risk, and other outcomes related to quality of life (QOL). To address this, the investigators have designed a novel physical activity intervention "Move More" that is designed to overcome many of the barriers to increasing physical activity in this population. This study aims to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in HD patients. The investigators primary hypothesis is that patients randomized to the Move More intervention will increase their physical activity levels more than those in the intradialytic exercise group. The main question it aims to answer is: • Does "Move More" increase the physical activity levels (minutes) measured through weekly minutes of physical activity and the LoPAQ questionnaire more than those in the standard intradialytic exercise program? For secondary outcomes this study aims to answer the following: * Does "Move More" improve the physical function of hemodialysis patients assessed by the short physical performance battery (SPBB) more than those in the standard intradialytic exercise program? * Does "Move More" decrease fatigue assess by the SONG-HD survey more than those in the standard intradialytic exercise program? * Does "Move More" decrease symptoms of depression assessed by PROMIS Depression Short Form 8a more than those in the standard intradialytic exercise program? * Does "Move More" increase the amount of exercise measured through a point system more than those in the standard intradialytic exercise program? * Does "Move More" improve blood pressure (BP) more than those in the standard intradialytic exercise program?

Recruiting
Has No Placebo

DCI Desert Dialysis

Kenneth R Wilud, PhD

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