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Blood Transfusion Strategies for Heart Attack Patients (TOP Trial)

N/A
Waitlist Available
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who undergo specific PAD-related operations including aortobifemoral or aortobiiliac bypass, open abdominal aortic aneurysm repair, visceral bypass, iliofemoral bypass, femoral bypass or endarterectomy, infrainguinal bypass, thromboembolectomy, supra-aortic trunk bypass, carotid endarterectomy, major lower extremity amputations, open cholecystectomy, small bowel resection, pancreatectomy, colon resection, rectal resection, splenectomy, transhiatal esophagectomy, liver resection, gastric resection, open ventral hernia repair, colostomies, intestinal anastomosis takedowns and revisions, gastric bypass, adrenalectomies, major diaphragmatic hiatal hernia repairs, open aneurysm repair, complex endovascular aneurysm repair, subclavian/vertebral bypasses and transpositions
Patients undergoing the above procedures will be included in the study regardless of their preoperative Hb level, and regardless of preoperative or intraoperative transfusion they might have received
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at hospital discharge, up to 1 year
Awards & highlights

TOP Trial Summary

This trial will compare two transfusion strategies in order to see which is associated with better outcomes in high-risk surgical patients.

Who is the study for?
This trial is for adults over 18 who've had certain major surgeries and have low hemoglobin levels post-operation. It's open to those with a history of heart disease or stroke, regardless of prior transfusions. Excluded are those unable to consent, unwilling to follow the protocol, with hereditary blood disorders, adverse reactions to blood products, non-English speakers, unstable after surgery, prisoners, active COVID-19 cases or pregnant women.Check my eligibility
What is being tested?
The study tests if giving blood transfusions at higher hemoglobin thresholds (Hb < 10 gm/dl) is safer than waiting until lower thresholds (Hb < 7 gm/dl) in high cardiac risk patients after major surgeries. The aim is to see which strategy better prevents complications like kidney injury or heart attacks.See study design
What are the potential side effects?
Potential side effects from receiving a blood transfusion can include allergic reactions such as fever and rash; lung injury; iron overload; immune system suppression; infection transmission although rare due to screening processes.

TOP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had surgery related to artery disease or for major organ removal.
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I am eligible for the study no matter my blood hemoglobin levels or if I've had blood transfusions.
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I am over 18 and my hemoglobin level was below 10gm/dl after surgery.
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I am a veteran who has had a stroke, heart disease, or artery disease and need surgery.

TOP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hospital discharge, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at hospital discharge, up to 1 year 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 endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization.
Secondary outcome measures
A composite endpoint of all-cause mortality
Cardiac Arrhythmia
Pneumonia
+2 more
Other outcome measures
The investigators will examine individual rates of the outcomes that consist of individual components of the primary endpoint.

TOP Trial Design

2Treatment groups
Experimental Treatment
Group I: RestrictiveExperimental Treatment1 Intervention
Transfusion trigger: Hb<7gm/dl
Group II: LiberalExperimental Treatment1 Intervention
Transfusion trigger: Hb<10gm/dl
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Transfusion
2018
N/A
~6450

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,302,584 Total Patients Enrolled
Panagiotis Kougias, MD MScStudy ChairBrooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY
1 Previous Clinical Trials
735 Total Patients Enrolled

Media Library

Blood Transfusion (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03229941 — N/A
Coronary Artery Bypass Research Study Groups: Restrictive, Liberal
Coronary Artery Bypass Clinical Trial 2023: Blood Transfusion Highlights & Side Effects. Trial Name: NCT03229941 — N/A
Blood Transfusion (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03229941 — N/A

Frequently Asked Questions

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

Are participants still being accepted for this experiment?

"As indicated on clinicaltrials.gov, applications for this medical study are now open. The original posting was registered on February 5th 2018, and the most recent update was done March 4th 2022."

Answered by AI

In what geographic regions is this clinical trial taking place?

"Presently, this trial is searching for candidates from 14 different locations. These sites are situated in Houston, Pittsburgh and Minneapolis as well as other cities scattered across the country. To make participating more convenient, you should select a site closest to your residence to reduce travel requirements."

Answered by AI

How many individuals have registered for this medical trial?

"To initiate this research project, 3070 eligible volunteers are required. Those wishing to take part can sign up at the Michael E. DeBakey VA Medical Center in Houston, Texas and the VA Pittsburgh Healthcare System University Drive Division in Pennsylvania's largest city."

Answered by AI
~425 spots leftby Mar 2025