Blood Transfusion Strategies for Heart Attack Patients
(TOP Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb \< 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb \< 7 gm/dl).

Research Team

Panagiotis Kougias, MD MSc

Principal Investigator

Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY

Eligibility Criteria

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.

Inclusion Criteria

I have had surgery related to artery disease or for major organ removal.

I am eligible for the study no matter my blood hemoglobin levels or if I've had blood transfusions.

I am over 18 and my hemoglobin level was below 10gm/dl after surgery.

See 1 more

Exclusion Criteria

I am a veteran with a genetic bleeding disorder.

Veteran unable to consent

You had a bad reaction to receiving blood before, like getting a fever, rash, or having your red blood cells break down.

See 10 more

Treatment Details

Interventions

Blood Transfusion (Other)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: RestrictiveExperimental Treatment1 Intervention

Transfusion trigger: Hb\<7gm/dl

Group II: LiberalExperimental Treatment1 Intervention

Transfusion trigger: Hb\<10gm/dl