Clinical trial NCT02972593: ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Official title: ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Atlanta Medical Center
First posted: 2016-11-23
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Trauma patients admitted to participating hospital with any Orthopaedic injury who have been determined to be stable by the Trauma Service (General Surgery) and are no longer within the resuscitation phase of initial treatment. This is defined as a normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood pressure greater than 90 mmHg for greater than 6 hours without fluid bolus or transfusion during that time
* Age 18-50
* Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery

Exclusion Criteria:

* Pregnant ( urine pregnancy test will be done as standard of care)
* Prisoner
* Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation)
* Known cardiac (coronary artery disease, atrial fibrillation, stent placement, congestive heart failure), renal (acute or chronic renal insufficiency or failure, defined as having Serum Creatinine \>1.2 at time of enrollment), liver (Childs C cirrhosis) or pulmonary disease (chronic obstructive pulmonary disease, abnormal pulmonary function tests or history of poor pulmonary function from any cause including acute traumatic conditions such as ARDS)
* Unlikely to follow up in the surgeon's estimation
* Sickle Cell Anemia
* History of cancer
* Preexisting weakness, paresthesias, deformities, or other conditions which might affect functional outcome in the surgeon's opinion
* Spinal cord injury
* Patients with burns expected to require operative treatment
* COVID positive

Primary outcomes:
measure: Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection
timeFrame: one year
Secondary outcomes:
measure: Combined Secondary Outcomes
timeFrame: one year
measure: Musculoskeletal Function Assessment
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University
name: Brian H Mullis, MD
role: PRINCIPAL_INVESTIGATOR
References: