At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 2,016 enrolled

Drug / intervention

Liberal (10 g/dL) Transfusion Strategy +1 morebiological

Likely dose

Liberal transfusion: maintain postoperative Hgb ≥10 g/dL through discharge or 30 days; Restrictive: transfuse for symptoms or Hgb <8 g/dLAI-extracted

Key inclusion· 3

✓Undergone surgical repair for hip fracture
✓Postoperative hemoglobin below 10 g/dL within 3 days of surgery
✓Diagnosis of cardiovascular disease (coronary artery disease, heart failure, stroke/TIA, peripheral vascular disease) OR cardiovascular risk factors (diabetes, hypertension, hypercholesterolemia, tobacco use, creatinine >2.0 mg/dL)

Key exclusion· 7

✕Unable to walk prior to hip fracture
✕Declines blood transfusions
✕Multiple traumas
✕Pathologic hip fracture due to malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00071032

NCT00071032Phase 3Completed

Compare CT.gov

Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)

Rutgers, The State University of New Jersey·interventional·Posted Oct 13, 2003·Updated Nov 16, 2020

In Brief

A Phase 3 clinical trial evaluating Liberal (10 g/dL) Transfusion Strategy and Restrictive (Symptomatic) Transfusion Strategy for Anemia and 7 related conditions. Completed, enrolled 2,016 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnemia, Hematologic Diseases, Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Thromboembolism, Pneumonia, Cerebrovascular Accident

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2003

First PostedOct 2003

Primary CompletionMay 2009

TodayJul 2026

First PostedOct 13, 2003

Enrollment StartJul 1, 2003

Primary CompletionMay 1, 2009

TodayJul 2, 2026

Enrollment to primary: 5.8 yearsPosted 22.7 years ago

Interventions

Liberal (10 g/dL) Transfusion Strategybiological

This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.

Restrictive (Symptomatic) Transfusion Strategybiological

Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.