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Antifibrinolytic Agent

Tranexamic Acid (TXA) for Deep Vein Thrombosis (POISE-3 Trial)

Phase 3
Waitlist Available
Led By PJ Devereaux, MD, PhD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing noncardiac surgery
D. History of stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after randomization
Awards & highlights

POISE-3 Trial Summary

This trial is testing whether tranexamic acid can help prevent bleeding during surgery, and whether it's better to avoid low or high blood pressure during surgery.

Eligible Conditions
  • Deep Vein Thrombosis
  • Perioperative Blood Loss
  • Arterial Thrombosis

POISE-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are currently having surgery that is not related to the heart.
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You have had a stroke in the past.
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You have a history of heart disease related to the arteries that supply blood to the heart.
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You have a history of peripheral arterial disease.

POISE-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A composite of MINS, non-hemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism.
A composite of life-threatening bleeding, major bleeding, and critical organ bleeding
Cardiac Arrest
Secondary outcome measures
A net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening,major or critical organ bleeding,MINS,stroke,peripheral arterial thrombosis,and symptomatic proximal venous thromboembolism
BIMS
For patients in the blood pressure management arm: MINS
+4 more
Other outcome measures
Acute kidney injury
All-cause mortality
Amputation
+43 more

POISE-3 Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Tranexamic Acid (TXA)Active Control1 Intervention
Patients will receive a 1g loading dose of intravenous TXA before surgery and a 1g loading dose of intravenous TXA at the end of surgery (wound closure).
Group II: Hypotension-avoidance strategyActive Control1 Intervention
Aims to avoid hypotension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).
Group III: Placebo (0.9% normal saline)Placebo Group1 Intervention
Patients will receive a 1g loading dose of placebo (0.9% normal saline) before surgery and a 1g loading dose of placebo (0.9% normal saline) at the end of surgery (wound closure).
Group IV: Perioperative hypertension-avoidance strategyPlacebo Group1 Intervention
Aims to avoid hypertension before surgery (preoperative), during surgery (intraoperative) and for the first 2 days after the day of surgery (postoperative).

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
154 Previous Clinical Trials
670,277 Total Patients Enrolled
PJ Devereaux, MD, PhDPrincipal InvestigatorHamilton Health Sciences Corporation
6 Previous Clinical Trials
16,586 Total Patients Enrolled

Frequently Asked Questions

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

Has the Food and Drug Administration (FDA) given its stamp of approval to Tranexamic Acid (TXA)?

"Tranexamic Acid (TXA) has received a 3 because it is in Phase 3 clinical trials. This suggests that while there is still some testing to be done, TXA has shown efficacy and multiple rounds of data support its safety."

Answered by AI

Is this research project still enrolling new participants?

"This study is no longer recruiting patients. The trial was originally posted on June 27, 2018 and the last update occurred on January 24, 2022. There are other studies currently underway that might be of interest; as of right now, there are 164 trials actively enrolling participants with venous thrombosis and 68 trials for Tranexamic Acid (TXA) admitting new patients."

Answered by AI

How is TXA most often used by doctors to help patients?

"TXA has shown to be an effective medication in the treatment of hyperfibrinolysis, hemophilia, and bleeding."

Answered by AI

How does the TXA research compare to similar investigations?

"First studied in 2010 at the First Affiliated Hospital of Guangzhou TCM University, TXA has undergone 223 clinical trials. As of right now, 68 more are ongoing with a large chunk taking place in Edmonton, Alberta."

Answered by AI

How many people are being chosen to participate in this clinical trial?

"This research is no longer actively recruiting patients. It was first posted on June 27th, 2018 and last updated January 24th, 2022. For those still seeking studies, there are 164 clinical trials for venous thrombosis and 68 for Tranexamic Acid (TXA) that are currently enrolling participants."

Answered by AI

Why did researchers design this clinical trial?

"The primary outcome of this study is a composite of life-threatening bleeding, major bleeding, and critical organ bleeding. This will be measured over the course of roughly 30 days after randomization. Secondary outcomes include BIMS (defined as the number of patients who experience bleeding independently associated with mortality after noncardiac surgery), a net risk-benefit outcome (defined as a composite of vascular death, and non-fatal life-threatening,major or critical organ bleeding,MINS,stroke,peripheral arterial thrombosis,and symptomatic proximal venous thromboembolism), and MINS"

Answered by AI
Recent research and studies
~1413 spots leftby Mar 2025