Trial · NCT03229941
Transfusion Trigger After Operations in High Cardiac Risk Patients
NCT03229941, Not applicable, Completed, VA Office of Research and Development; results first posted 2025-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Transfusion Trigger After Operations in High Cardiac Risk Patients. Trials, record NCT03229941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03229941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Transfusion Trigger After Operations in High Cardiac Risk Patients
- NCT number
- NCT03229941
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,424 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Myocardial Infarction, Coronary Revascularization, Acute Renal Failure
- Interventions
- Blood Transfusion
- First posted
- 2017-07-26
- Last updated
- 2025-11-21
- Results first posted
- 2025-09-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 graft, or percutaneous coronary intervention (either angioplasty or stenting). Stroke will be defined as new unilateral neurological deficit that lasts for more than 24 hours, and is confirmed by a brain imaging modality (computed tomography or magnetic resonance imaging study) demonstrating new brain infarct. |
| Secondary | A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis | 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 will be defined as a combination of two of the following systemic inflammatory response syndrome (SIRS) criteria, plus suspected or present source of infection. SIRS criteria will include the following: temperature greater than 38C, heart rate greater than 90 beats/min, WBC \> 12,000 or \< 4,000, or \> 10% bands. |
| Secondary | 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 | 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 results in loss of consciousness and absence of circulating blood flow as evidenced by absent carotid pulse. Only episodes of cardiac arrest that are reversed will be collected under this endpoint. If they are not reversed the event will be categorized as death. |
| Secondary | All-cause Mortality at 1 Year After Randomization | 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. |
| Secondary | A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke | 30 days after randomization | A composite endpoint of all-cause mortality, MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke. |
| Secondary | Length of Hospital Stay | At hospital discharge, up to 1 year | Length of hospital stay. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 90 days after randomization | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis | 90 days after randomization | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 90 days after randomization | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause Mortality at 1 Year After Randomization | 12 months after randomization | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke | 30 days after randomization | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Hospital Stay | At hospital discharge, up to 1 year | Intent to Treat population | days | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Restrictive | 71 | Participants | ||
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 | Liberal | 61 | Participants | ||
| A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis | Restrictive | 100 | Participants | ||
| A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis | Liberal | 103 | Participants | ||
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 | Restrictive | 67 | Participants | ||
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 | Liberal | 38 | Participants | ||
| All-cause Mortality at 1 Year After Randomization | Restrictive | 105 | Participants | ||
| All-cause Mortality at 1 Year After Randomization | Liberal | 94 | Participants | ||
| A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke | Restrictive | 45 | Participants | ||
| A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke | Liberal | 33 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Restrictive | 712 | |
| Overall Study | STARTED | Liberal | 712 | |
| Overall Study | COMPLETED | Restrictive | 667 | |
| Overall Study | COMPLETED | Liberal | 636 | |
| Overall Study | NOT COMPLETED | Restrictive | 45 | |
| Overall Study | NOT COMPLETED | Liberal | 76 |
Source ClinicalTrials.gov
Adverse events684
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Restrictive | 15 | 712 | 15 |
| serious | Anaemia | Blood and lymphatic system disorders | Liberal | 6 | 712 | 6 |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | Restrictive | 0 | 712 | 0 |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | Liberal | 2 | 712 | 2 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Restrictive | 1 | 712 | 1 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Liberal | 0 | 712 | 0 |
| serious | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Restrictive | 1 | 712 | 1 |
| serious | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Liberal | 0 | 712 | 0 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Restrictive | 1 | 712 | 1 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Liberal | 1 | 712 | 1 |
1 to 10 of 684Source ClinicalTrials.gov
See all 684 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Restrictive | 105 | 701 |
| Total, all-cause mortality | Liberal | 94 | 668 |
| Total, other adverse events | Restrictive | 0 | 0 |
| Total, other adverse events | Liberal | 0 | 0 |
| Total, serious adverse events | Restrictive | 386 | 712 |
| Total, serious adverse events | Liberal | 372 | 712 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Restrictive vs Liberal: All-cause Mortality at 1 Year After Randomization | Trial comparisons |
| Restrictive vs Liberal: A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke | Trial comparisons |
Restrictive vs Liberal: 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 | Trial comparisons |
Restrictive vs Liberal: 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 | Trial comparisons |
| Restrictive vs Liberal: deaths from any cause | Trial comparisons |
| Restrictive vs Liberal: A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis | Trial comparisons |
| Restrictive vs Liberal: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03229941
GET https://conductscience.org/api/trials/v1/NCT03229941/events?page=2