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Anticoagulant

Anticoagulation Strategies for Blood Clots in Cancer Patients

Q: Is enrollment still available for the clinical trial?

Affirmative. The data available on clinicaltrials.gov reveals that this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> trial, which was first posted on August 29th 2022, is actively recruiting patients. A total of 50 participants must be enrolled from a single site.

Q: What is the overall number of participants in this trial?

Correct. According to clinicaltrials.gov, the trial was first announced on August 29th 2022 and has since been actively recruiting patients. The aim is to acquire 50 participants from a single treatment site.

Q: What potential health risks are associated with the use of Modified dose LMWH?

There is substantial clinical evidence affirming the safety of modified-dose LMWH, consequently it has been awarded a score of 3.

Phase 4

Recruiting

Led By Tzu-Fei Wang, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Thrombocytopenia with a platelet count < 50,000/uL from cancer therapy or malignancy itself

Objectively confirmed VTE within last 14 days for which therapeutic anticoagulation is planned

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial is for cancer patients who have blood clots and low platelet counts. The investigators will compare two treatment strategies: full dose blood thinners with platelet transfusions or reduced dose blood thinners without transfusions.

Who is the study for?

This trial is for adults over 18 with active cancer and a low platelet count due to cancer or its treatment. They must have had a blood clot within the last two weeks and be able to give consent. People can't join if they've been on blood thinners for more than 72 hours, expect to live less than a month, have severe kidney issues, are allergic to heparin products, have other causes of low platelets, refuse blood products, or where any anticoagulation is unsafe.Check my eligibility

What is being tested?

The study tests two strategies in patients with cancer who also have clots and low platelets: one group will receive full-dose blood thinners plus platelet transfusions; the other gets reduced-dose thinners without transfusions. The goal is to find out which method works best without causing excessive bleeding.See study design

What are the potential side effects?

Blood thinners like Dalteparin, Tinzaparin, and Enoxaparin may cause bleeding problems especially when combined with low platelet counts. Other side effects include irritation at injection sites, allergic reactions, osteoporosis with long-term use, and increased risk of further clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My platelet count is below 50,000 due to cancer or its treatment.

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I have had a blood clot confirmed in the last 14 days and will be treated with blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility - The average number of patients recruited per month

Secondary outcome measures

Clinical Outcome - Composite of recurrent VTE and major bleeding events

Clinical Outcome - Duration of thrombocytopenia (days of platelet count < 50,000/uL) per patient

Clinical Outcome - Health-related quality of life using EuroQoL-EQ-5D-5L questionnaire

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Modified dose LMWH without platelet transfusion supportExperimental Treatment3 Interventions

Patients will be given modified dose LMWH as below based on the first platelet count of the day (daily in admitted patients or at least 2 times a week in outpatients), without empiric platelet transfusion: I. Platelet count 25-50,000/µL: 50% dose LMWH II. Platelet count < 25,000/µL: hold anticoagulation

Group II: Higher dose LMWH with platelet transfusion supportActive Control3 Interventions

Patients assigned to higher dose LMWH (see below) will be given transfusion for 14 days when the first platelet count of the day falls below 50,000/uL (daily inpatient or at least 2 times a week in outpatients). Post-transfusion counts will not be routinely obtained unless clinically indicated I. Platelet count 25-50,000/µL: platelet transfusion + 100% dose LMWH II. Platelet count < 25,000/µL: platelet transfusion + 50% dose LMWH After Day 14, patients will be transitioned to modified dose LMWH as the other arm without platelet transfusion. LMWH can include enoxaparin, dalteparin, or tinzaparin, with 100% as: Enoxaparin - 1mg/kg subcutaneously twice daily Dalteparin - 200 IU/kg subcutaneously daily for 1 month then 150 U/kg daily Tinzaparin - 175 units/kg subcutaneously daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalteparin

FDA approved

Tinzaparin

FDA approved

Enoxaparin

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,641 Total Patients Enrolled

16 Trials studying Thrombosis

8,405 Patients Enrolled for Thrombosis

Tzu-Fei Wang, MDPrincipal InvestigatorOttawa Hospital Research Institute

1 Previous Clinical Trials

21 Total Patients Enrolled

Marc Carrier, MDPrincipal InvestigatorOttawa Hospital Research Institute

4 Previous Clinical Trials

1,543 Total Patients Enrolled

1 Trials studying Thrombosis

260 Patients Enrolled for Thrombosis

Media Library

Dalteparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05255003 — Phase 4

Thrombosis Research Study Groups: Modified dose LMWH without platelet transfusion support, Higher dose LMWH with platelet transfusion support

Thrombosis Clinical Trial 2023: Dalteparin Highlights & Side Effects. Trial Name: NCT05255003 — Phase 4

Dalteparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05255003 — Phase 4

Frequently Asked Questions

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

Is enrollment still available for the clinical trial?

"Affirmative. The data available on clinicaltrials.gov reveals that this experimental trial, which was first posted on August 29th 2022, is actively recruiting patients. A total of 50 participants must be enrolled from a single site."

Answered by AI

What is the overall number of participants in this trial?

"Correct. According to clinicaltrials.gov, the trial was first announced on August 29th 2022 and has since been actively recruiting patients. The aim is to acquire 50 participants from a single treatment site."

Answered by AI