Trial · NCT00071032
Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
NCT00071032, Phase 3, Completed, Rutgers, The State University of New Jersey; results first posted 2014-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease. Trials, record NCT00071032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00071032
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
- NCT number
- NCT00071032
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,016 participants, actual
- Lead sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Anemia, Hematologic Diseases, Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Thromboembolism, Pneumonia, Cerebrovascular Accident
- Interventions
- Liberal (10 g/dL) Transfusion Strategy, Restrictive (Symptomatic) Transfusion Strategy
- First posted
- 2003-10-13
- Last updated
- 2020-11-16
- Results first posted
- 2014-08-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death | 60 days after randomization | ascertained via telephone follow-up |
| Secondary | Myocardial Infarction, Unstable Angina, or Death for Any Reason | In-hospital | |
| Secondary | Mortality at 30 Days | 30 days | |
| Secondary | Mortality at 60 Days | 60 Days | |
| Secondary | Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke | In-hospital | |
| Secondary | Myocardial Infarction | In-hospital | |
| Secondary | Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke) | In hospital | |
| Secondary | Disposition Status (i.e., Nursing Home Placement) | 60 days | Nursing Home Residence |
| Secondary | Function - Lower Extremity Activities of Daily Living,at 30 Days | 30 days | Using the Functional Status Index, score range 0 to 11, higher scores indicate greater dependency |
| Secondary | Function - Instrumental Activities of Daily Living, at 30 Days | 30 days | Using the Older Americans Resources and Services Functional Assessment Questionnaire, score range from 0 to 4, higher scores indicating greater dependency |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death | 60 days after randomization | participants | NUMBER | |
| SECONDARY | Myocardial Infarction, Unstable Angina, or Death for Any Reason | In-hospital | participants | NUMBER | |
| SECONDARY | Mortality at 30 Days | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality at 60 Days | 60 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke | In-hospital | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Myocardial Infarction | In-hospital | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke) | In hospital | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disposition Status (i.e., Nursing Home Placement) | 60 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Function - Lower Extremity Activities of Daily Living,at 30 Days | 30 days | score on a scale | MEAN | |
| SECONDARY | Function - Instrumental Activities of Daily Living, at 30 Days | 30 days | score on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death | Liberal (10 g/dL) Transfusion Strategy | 351 | participants | ||
| Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death | Restrictive Strategy | 347 | participants | ||
| Myocardial Infarction, Unstable Angina, or Death for Any Reason | Liberal (10 g/dL) Transfusion Strategy | 43 | participants | ||
| Myocardial Infarction, Unstable Angina, or Death for Any Reason | Restrictive Strategy | 52 | participants | ||
| Mortality at 30 Days | Liberal (10 g/dL) Transfusion Strategy | 52 | Participants | ||
| Mortality at 30 Days | Restrictive Strategy | 43 | Participants | ||
| Mortality at 60 Days | Liberal (10 g/dL) Transfusion Strategy | 76 | Participants | ||
| Mortality at 60 Days | Restrictive Strategy | 66 | Participants | ||
| Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke | Liberal (10 g/dL) Transfusion Strategy | Death, myocardial infarction, or pneumonia | 89 | Participants | |
| Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke | Restrictive Strategy | Death, myocardial infarction, or pneumonia | 90 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liberal (10 g/dL) Transfusion Strategy | 1,007 | |
| Overall Study | STARTED | Restrictive Strategy | 1,009 | |
| Overall Study | COMPLETED | Liberal (10 g/dL) Transfusion Strategy | 998 | |
| Overall Study | COMPLETED | Restrictive Strategy | 1,001 | |
| Overall Study | NOT COMPLETED | Liberal (10 g/dL) Transfusion Strategy | 9 | |
| Overall Study | NOT COMPLETED | Restrictive Strategy | 8 |
Source ClinicalTrials.gov
Adverse events10
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 | Death at 60 days | General disorders | Liberal (10 g/dL) Transfusion Strategy | 76 | 998 | 76 |
| serious | Death at 60 days | General disorders | Restrictive Strategy | 66 | 1,001 | 66 |
| serious | Myocardial Infarction | Cardiac disorders | Liberal (10 g/dL) Transfusion Strategy | 23 | 1,005 | 23 |
| serious | Myocardial Infarction | Cardiac disorders | Restrictive Strategy | 38 | 1,008 | |
| serious | Unstable Angina | Cardiac disorders | Liberal (10 g/dL) Transfusion Strategy | 2 | 1,005 | 2 |
| serious | Unstable Angina | Cardiac disorders | Restrictive Strategy | 3 | 1,008 | 3 |
| serious | Congestive Heart Failure | Cardiac disorders | Liberal (10 g/dL) Transfusion Strategy | 27 | 1,005 | 27 |
| serious | Congestive Heart Failure | Cardiac disorders | Restrictive Strategy | 35 | 1,007 | 35 |
| serious | Stroke | Vascular disorders | Liberal (10 g/dL) Transfusion Strategy | 8 | 1,005 | 8 |
| serious | Stroke | Vascular disorders | Restrictive Strategy | 3 | 1,007 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liberal (10 g/dL) Transfusion Strategy | ||
| Total, all-cause mortality | Restrictive Strategy | ||
| Total, other adverse events | Liberal (10 g/dL) Transfusion Strategy | 0 | 1,007 |
| Total, other adverse events | Restrictive Strategy | 0 | 1,009 |
| Total, serious adverse events | Liberal (10 g/dL) Transfusion Strategy | 76 | 1,007 |
| Total, serious adverse events | Restrictive Strategy | 66 | 1,009 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HL073958 | FOCUS | CARSON, JEFFREY LEE | UNIV OF MED/DENT NJ-R W JOHNSON MED SCH | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2003 to 2011 | NIH RePORTER |
| U01HL074815 | FOCUS Data Coordinating Center | TERRIN, MICHAEL L | UNIVERSITY OF MARYLAND BALTIMORE | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2003 to 2010 | NIH RePORTER |
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: Myocardial Infarction | Trial comparisons |
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: Disposition Status (i.e., Nursing Home Placement) | Trial comparisons |
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: Myocardial Infarction, Unstable Angina, or Death for Any Reason | Trial comparisons |
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: Mortality at 30 Days | Trial comparisons |
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death | Trial comparisons |
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: Mortality at 60 Days | Trial comparisons |
| Liberal (10 g/dL) Transfusion Strategy vs Restrictive Strategy: 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/NCT00071032
GET https://conductscience.org/api/trials/v1/NCT00071032/results?page=2