Phase 4
Completed N=100
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Source: ClinicalTrials.gov NCT02972593 ↗Enrolled (actual)
100
Serious AEs
13.1%
Results posted
Jun 2023
Primary outcomePrimary: Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection — 12; 3 Participants — p=.0122
◆ Published Evidence
Emerging
12citations · ~6 / year
Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study.
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).
Linked Publications (2)
-
Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study.
-
Early Results of Orthopaedic Trauma and Anemia: Conservative Versus Liberal Transfusion Strategy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection |
12; 3 | .0122 sig |
| SECONDARY Combined Secondary Outcomes |
7; 6 | .7742 |
| SECONDARY Musculoskeletal Function Assessment |
35.9; 28.2 | .1443 |
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
Data sourced from ClinicalTrials.gov (NCT02972593) and the linked publication. 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. Informational only — not medical advice.