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Antifibrinolytic Agent

Tranexamic Acid for Blood Cancer Patients Undergoing Stem Cell Transplant (PATH Trial)

Phase 3

Recruiting

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

Adults 18 years or older undergoing ASCT for a hematologic malignancy

Be older than 18 years old

Must not have

A previous WHO grade 2, 3 or 4 bleeding event within the past year

Significant renal impairment (creatinine more than 1.5 times the upper limit of normal or a eGFR less than 0.5 mL/min/1.78m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether giving TXA to patients before their ASCT can help prevent or reduce problems with bleeding.

Who is the study for?

This trial is for adults over 18 with blood cancers undergoing autologous stem cell transplantation. They must consent to the treatment plan and not need anticoagulant drugs during the procedure. People with color vision disturbances, recent thrombosis, urinary bleeding, allergies to Tranexamic Acid, active angina, platelet transfusion issues due to HLA antibodies, significant past bleeding events or renal impairment can't participate.

What is being tested?

The PATH III Trial is testing if using prophylactic oral and intravenous Tranexamic Acid (TXA) combined with therapeutic platelet transfusions when needed is safer and more effective than just regular preventive platelet transfusions in patients having a stem cell transplant for treating blood cancers.

What are the potential side effects?

Tranexamic Acid may cause side effects such as nausea, diarrhea, muscle cramps or pain. It could also increase the risk of clotting problems like deep vein thrombosis or pulmonary embolism especially in people who are already at risk for these conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and having a stem cell transplant for blood cancer.

Exclusion Criteria

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

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I had a serious bleeding event in the last year.

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My kidney function is significantly impaired.

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I have a genetic blood clotting or bleeding disorder.

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I have had a clot in my lung, leg, or brain without a clear cause.

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I need blood-thinning medication during my stem cell transplant.

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I experience chest pain, whether I'm moving or not.

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I have developed color vision problems (not born with it).

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I have a history of not responding to platelet transfusions due to HLA antibodies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Adverse reactions related to platelet transfusion

Adverse reactions related to tranexamic acid

Bleeding Severity Measurement Scale (BSMS) for bleeding events Grade 2 or higher

+7 more

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035

Postoperative wound infection

Postoperative wound infection after release from hospital

Myocardial infaction

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tranexamic Acid

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic Tranexamic AcidExperimental Treatment1 Intervention

Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.

Group II: Prophylactic Platelet TransfusionActive Control1 Intervention

Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic Acid

2011

Completed Phase 4

~2740

0 / 9Eligibility criteria met