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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PATH 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.Check my eligibility

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.See study design

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.

PATH Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

PATH Trial 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

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

Primary outcome measures

Hemorrhage

Secondary outcome measures

Adverse reactions related to platelet transfusion

Adverse reactions related to tranexamic acid

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

+16 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

PATH 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alberta Cancer FoundationOTHER

17 Previous Clinical Trials

4,971 Total Patients Enrolled

1 Trials studying Blood Cancers

152 Patients Enrolled for Blood Cancers

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,029 Total Patients Enrolled

Media Library

Tranexamic Acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04448184 — Phase 3

Blood Cancers Research Study Groups: Prophylactic Tranexamic Acid, Prophylactic Platelet Transfusion

Blood Cancers Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT04448184 — Phase 3

Tranexamic Acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04448184 — Phase 3

Frequently Asked Questions

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

What is the side effect profile of Tranexamic Acid?

"There is already some evidence to support the efficacy of Tranexamic Acid, as well as data from multiple rounds of testing that confirm its safety. Therefore, we have rated it a 3 on our scale."

Answered by AI

Could you provide more information about the screening process for this research project?

"Yes, as of today this trial is still recruiting patients. It was originally posted on February 16th, 2022 and the most recent update was June 27th, 2022 according to clinicaltrials.gov"

Answered by AI

How many people are taking part in this experiment?

"That is correct, the trial is ongoing. According to the clinicaltrials.gov website, this study was first posted on February 16th, 2022 and updated June 27th, 2022. They are currently recruiting 662 participants from 11 different centres."

Answered by AI

Could you provide some historical context for Tranexamic Acid research?

"As of right now, there are 68 clinical trials underway that are studying Tranexamic Acid. Out of these, 29 studies have reached Phase 3. Additionally, although several investigations for Tranexamic Acid originate from Kansas City in Kansas, there are a total of 304 medical centres conducting research on this topic."

Answered by AI

What are some common applications for Tranexamic Acid?

"Tranexamic Acid is most commonly used to treat hyperfibrinolysis, but it can also help with conditions like hemophilia and excessive bleeding following a tooth extraction."

Answered by AI

At how many locations is this trial currently being conducted?

"Presently, this 11 different sites are running this clinical trial. Some of the locations where patients can participate include Halifax, Ottawa and Toronto. If you decide to join this trial, try to select a location nearest to you to limit travel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)

2022. "Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04448184.

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