CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 161 enrolled
Drug / intervention
Blood and blood products for transfusionbiological
Likely dose
Blood transfusion to either keep Hgb >7 g/dL (liberal arm) or defer until Hgb <5.5 g/dL (conservative arm)AI-extracted
Key inclusion· 3
  • Trauma patients with orthopedic injury admitted to hospital, hemodynamically stable, no longer in acute resuscitation phase (normal urine output >0.5 ml/kg/hr and SBP >90 mmHg for >6 hours without fluid bolus or transfusion)
  • Age 18–50 years
  • Hemoglobin <9 g/dL at enrollment or expected to drop below 9 g/dL with planned surgery
Key exclusion· 14
  • Pregnant (as confirmed by urine pregnancy test)
  • Prisoner
  • Severe head injury (Glasgow Coma Scale <8 for 48+ hours from presentation)
  • Known cardiac disease (coronary artery disease, atrial fibrillation, stent placement, congestive heart failure)

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

Search/NCT02972593
NCT02972593Phase 4Completed

ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion

Indiana University·interventional·Posted Nov 23, 2016·Updated Jun 29, 2023

In Brief

A Phase 4 clinical trial evaluating Blood and blood products for transfusion for Anemia. Completed, enrolled 161 participants.

Detailed Summary

The purpose of this study is to determine if there is a difference in outcomes between liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and conservative transfusion (transfusing when hemoglobin drops below a set lower value number).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
Countries--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 23, 2016
Enrollment StartMar 1, 2014
Primary CompletionJun 24, 2022
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 9.6 years ago

Interventions

Blood and blood products for transfusionbiological

Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb \>7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.