← Back to Search

Anticoagulant

Pre-operative Enoxaparin for Blood Clots

Phase 4
Recruiting
Led By Thomas Wertin, MD, FACS
Research Sponsored by Valleywise Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the study up to 2 years
Awards & highlights

Study Summary

This trial is testing whether it's better to give a blood-thinning drug before or after surgery to people with orthopedic injuries.

Who is the study for?
This trial is for adults over 18 who are in the ICU due to traumatic injuries needing surgery on long bones or pelvis. It's not for those under 18, pregnant, prisoners, directly admitted to OR without ICU stay, with brain hemorrhage, severe kidney issues requiring dialysis or already have a blood clot.Check my eligibility
What is being tested?
The study tests if giving Enoxaparin (a blood thinner) before surgery is safe and effective compared to after surgery in preventing blood clots. Participants will be randomly assigned to receive either Enoxaparin or a placebo before their operation.See study design
What are the potential side effects?
Possible side effects include increased risk of bleeding during and after surgery. Since it's aimed at preventing deep vein clots, there may also be risks associated with thinning the blood too much.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the study up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the study up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemorrhage
Evaluate Other Complications (besides bleeding) Related to DVT chemoprophylaxis
Secondary outcome measures
Assess feasibility of a larger trial with respect to study design
Incidence of DVT and PE
study duration

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EnoxaparinActive Control1 Intervention
Enoxaparin dose will not be held for surgical procedure.
Group II: Placebo dose given and Enoxaparin dose heldPlacebo Group1 Intervention
Enoxaparin dose will be held and replaced by placebo and not given prior to surgical procedure.

Find a Location

Who is running the clinical trial?

Valleywise HealthLead Sponsor
14 Previous Clinical Trials
3,804 Total Patients Enrolled
Thomas Wertin, MD, FACSPrincipal InvestigatorValleywise Health

Media Library

Enoxaparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05081375 — Phase 4
Blood Loss Research Study Groups: Enoxaparin, Placebo dose given and Enoxaparin dose held
Blood Loss Clinical Trial 2023: Enoxaparin Highlights & Side Effects. Trial Name: NCT05081375 — Phase 4
Enoxaparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081375 — Phase 4

Frequently Asked Questions

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

Has Enoxaparin received authorization from the FDA?

"Having already been approved, Enoxaparin received a safety rating of 3 out of the possible maximum score."

Answered by AI

What is the main focus of this clinical investigation?

"The primary objective of this clinical trial, which will be evaluated over a 24 hour period post-surgery, is to explore the risk for bleeding complications related to deep vein thrombosis (DVT) chemoprophylaxis. Secondary aims involve assessing the feasibility of launching a larger study by gauging its design and duration as well as recording any incidence of DVT or pulmonary embolism."

Answered by AI

How many individuals are partaking in this clinical research endeavor?

"Affirmative, according to clinicaltrials.gov this research endeavour is still seeking participants. It was initially uploaded on December 16th 2019 and the most recent update occurred October 21st 2022 - 60 individuals are needed across a single medical centre."

Answered by AI

What maladies is Enoxaparin typically prescribed to address?

"Enoxaparin is a highly versatile medication, primarily used to treat diarrhea but also useful for general surgical procedures, urine alkalinization therapy, and sodium depletion."

Answered by AI

Has Enoxaparin been researched in any other scientific experiments?

"As of now, 119 studies exploring Enoxaparin are in progress with 31 trials currently at Phase 3. Out of the 747 locations worldwide running these tests, several can be found in Calgary, Alberta."

Answered by AI

Are there opportunities for enrolment in this trial?

"Affirmative. The clinical trial is actively recruiting as attested to by the information on clinicaltrials.gov; it was first made available on December 16th 2019 and amended most recently on October 21st 2022. 60 participants are needed from just one medical centre for this study."

Answered by AI
~11 spots leftby Apr 2025