Phase 3
N=2,016
Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
Anemia · Hematologic Diseases · Cardiovascular Diseases · Heart Diseases · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00071032 ↗Enrolled (actual)
2,016
Serious AEs
7.0%
Results posted
Aug 2014
Primary outcome: Primary: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death — 351; 347 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liberal (10 g/dL) Transfusion Strategy (Biological); Restrictive (Symptomatic) Transfusion Strategy (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death |
351; 347 | — |
| SECONDARY Myocardial Infarction, Unstable Angina, or Death for Any Reason |
43; 52 | — |
| SECONDARY Mortality at 30 Days |
52; 43 | — |
| SECONDARY Mortality at 60 Days |
76; 66 | — |
| SECONDARY Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke |
89; 90; 103; 94 | — |
| SECONDARY Myocardial Infarction |
23; 38 | — |
| SECONDARY Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke) |
14; 8; 12; 8; 8; 3 | — |
| SECONDARY Disposition Status (i.e., Nursing Home Placement) |
137; 161 | — |
| SECONDARY Function - Lower Extremity Activities of Daily Living,at 30 Days |
7.3; 7.4 | — |
| SECONDARY Function - Instrumental Activities of Daily Living, at 30 Days |
3.9; 3.9 | — |
| SECONDARY Function - Fatigue/Energy, at 30 Days |
38.7; 38.6 | — |
| SECONDARY Function - Lower Extremity Activities of Daily Living. at 60 Days |
5.1; 5.1 | — |
| SECONDARY Function - Instrumental Activities of Daily Living, at 60 Days |
3.7; 3.7 | — |
| SECONDARY Function - Fatigue/Energy, at 60 Days |
41.8; 42.3 | — |
| SECONDARY Length of Stay in Hospital for United States Participants |
3.67; 3.97 | — |
| SECONDARY Length of Stay in Hospital for Canadian Participants |
12.03; 12.70 | — |
Summary
The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.
Eligibility Criteria
Inclusion Criteria
- Has undergone surgical repair for a hip fracture
- Has a postoperative Hgb level below 10 g/dL within three days of surgery
- Diagnosis of cardiovascular disease (e.g., coronary artery disease, congestive heart failure, stroke or transient ischemic attack, or peripheral vascular disease) or cardiovascular risk factors (e.g., diabetes mellitus, hypertension, hypercholesterolemia, tobacco use, or creatinine levels greater than 2.0 mg/dL)
Exclusion Criteria
- Unable to walk prior to hip fracture
- Declines blood transfusions
- Suffered multiple traumas
- Pathologic fracture of the hip due to malignancy
- Clinically recognized acute myocardial infarction within the 30 days prior to study entry
- Previously participated in the trial and fractured the other hip
- Symptoms associated with anemia (e.g., ischemic chest pain) or actively bleeding at the time of randomization
Data sourced from ClinicalTrials.gov (NCT00071032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.