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Anticoagulant

Anticoagulation Strategies for Blood Clots in Cancer Patients

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

Must not have

Superficial vein thrombosis only

Thrombocytopenia from other causes, such as thrombotic microangiopathy, immune thrombocytopenia, disseminated intravascular coagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a clot in a vein near the surface of my body.

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I have a low platelet count not caused by common blood disorders.

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My body has resisted platelet transfusions due to HLA antibodies.

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I cannot take LMWH due to a bad reaction in the past.

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I refuse to receive blood transfusions.

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I cannot take blood thinners due to bleeding risks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility - The average number of patients recruited per month

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 / 8Eligibility criteria met