ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion — ORACL  

Anemia Clinical Trial

Official title: ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion

Status Completed

Clinical Trial 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).

Clinical Trial Description

Transfusion of Orthopaedic trauma patients is routinely done in asymptomatic individuals as there is no accepted national standard or recommendations from the American Academy of Orthopaedic Surgeons or the Orthopaedic Trauma Association for what level of anemia is appropriate in an asymptomatic patient. Individual practitioners typically make this decision based on anecdotal experiences and expert opinion. No prospective study has been performed to date to answer this question in this patient population.

The null hypothesis of this proposed pilot study is that no difference will be seen with a liberal transfusion strategy to keep a patient's hemoglobin above 7 g/dL versus a conservative strategy to keep the patient's hemoglobin above 5.5 g/dL in patients asymptomatic at rest. The primary outcome of this pilot study will be infection; defined as postoperative wound infection (superficial or deep) or other perioperative infection but not surgical site (urinary tract infection or pneumonia). Deep infection is defined as the need for intravenous antibiotics or a return to surgery for debridement. Superficial infection is defined as the use of oral antibiotics only successfully treat a surgical site infection. Secondary outcomes will include pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death, and the musculoskeletal functional assessment. ;

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT02972593
• Study type: Interventional
• Source: Indiana University
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Completion date: June 24, 2022