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NCT03229941: TOP

Transfusion Trigger After Operations in High Cardiac Risk Patients

Completed NA Results posted Last updated 21 November 2025
What this trial tests

NA trial testing Blood Transfusion in Myocardial Infarction in 1,424 participants. Completed in 2 March 2024.

Timeline
5 February 2018
Primary endpoint
2 June 2023
2 March 2024

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment1,424
Start date5 February 2018
Primary completion2 June 2023
Estimated completion2 March 2024
Sites16 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Myocardial Infarction or Coronary Revascularization. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 90 days after randomization

MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graf

GroupValue95% CI
Restrictive71
Liberal61
A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis Secondary · 90 days after randomization

Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively. Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy. Sepsis wil

GroupValue95% CI
Restrictive100
Liberal103
A Composite Endpoint of Cardiac Complications (Other Than MI) at 90 Days Post-randomization: Cardiac Complications Include New Cardiac Arrhythmias That Necessitate New Treatment, New or Worsening Congestive Heart Failure, and Non Fatal Cardiac Arrest Secondary · 90 days after randomization

The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded. CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment. Cardiac arrest will be defined as the cessation of cardiac pump function activity that

GroupValue95% CI
Restrictive67
Liberal38
All-cause Mortality at 1 Year After Randomization Secondary · 12 months after randomization

The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the Death Ascertainment File.

GroupValue95% CI
Restrictive105
Liberal94
A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke Secondary · 30 days after randomization

A composite endpoint of all-cause mortality, MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.

GroupValue95% CI
Restrictive45
Liberal33
Length of Hospital Stay Secondary · At hospital discharge, up to 1 year

Length of hospital stay.

GroupValue95% CI
Restrictive5.03.0 – 8.0
Liberal5.03.0 – 8.0

Adverse events — posted to ClinicalTrials.gov

Time frame: All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Restrictive
Serious: 386/712 (54%)
Deaths: 105/701
Liberal
Serious: 372/712 (52%)
Deaths: 94/668

Serious adverse events (342 terms)

ReactionSystemRestrictiveLiberal
Wound infectionInfections and infestations
Cardiac failure congestiveCardiac disorders
Myocardial infarctionCardiac disorders
SepsisInfections and infestations
Acute kidney injuryRenal and urinary disorders
Atrial fibrillationCardiac disorders
Wound complicationInjury, poisoning and procedural complications
Leg amputationSurgical and medical procedures
Gastrointestinal haemorrhageGastrointestinal disorders
PneumoniaInfections and infestations
AnaemiaBlood and lymphatic system disorders
Urinary tract infectionInfections and infestations
CellulitisInfections and infestations
Post procedural haematomaInjury, poisoning and procedural complications
HypotensionVascular disorders
OsteomyelitisInfections and infestations
Wound dehiscenceInjury, poisoning and procedural complications
Acute respiratory failureRespiratory, thoracic and mediastinal disorders
Cardiac deathGeneral disorders
Clostridium difficile infectionInfections and infestations
GangreneInfections and infestations
Vascular graft occlusionInjury, poisoning and procedural complications
AmputationSurgical and medical procedures
Toe amputationSurgical and medical procedures
Cerebrovascular accidentNervous system disorders

Most-reported serious reactions: Wound infection, Cardiac failure congestive, Myocardial infarction, Sepsis, Acute kidney injury, Atrial fibrillation, Wound complication, Leg amputation.

Data from ClinicalTrials.gov NCT03229941 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Transfusion thresholds for guiding red blood cell transfusion.
    Carson JL, Stanworth SJ, Dennis JA, Trivella M, et al · · 2021 · cited 165× · PMID 34932836 · DOI 10.1002/14651858.cd002042.pub5
  2. Transfusion trigger after operations in high cardiac risk patients (TOP) trial protocol. Protocol for a multicenter randomized controlled transfusion strategy trial.
    Kougias P, Mi Z, Zhan M, Carson JL, et al · · 2023 · cited 5× · PMID 36690072 · DOI 10.1016/j.cct.2023.107095
  3. Liberal or Restrictive Postoperative Transfusion in Patients at High Cardiac Risk: The TOP Randomized Clinical Trial.
    Kougias P, Sharath SE, Zhan M, Carson JL, et al · · 2025 · cited 3× · PMID 41205227 · DOI 10.1001/jama.2025.20841

Verify or expand the search:

Other trials of Blood Transfusion

Trials testing the same drug.

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03229941.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing