ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion

NCT ID: NCT02972593

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2022-06-24

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liberal

Blood and blood products for transfusion. Transfusion will be done to keep Hgb \>7 g/dL.

Group Type: OTHER

Blood and blood products for transfusion

Intervention Type: BIOLOGICAL

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.

Conservative

Blood and blood products for transfusion. Transfusion will be done to keep Hgb \> 5.5 g/dL.

Group Type: OTHER

Blood and blood products for transfusion

Intervention Type: BIOLOGICAL

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.

Interventions

Blood and blood products for transfusion

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlanta Medical Center

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Brian Mullis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian H Mullis, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

References

Mullis BH, Mullis LS, Kempton LB, Virkus W, Slaven JE, Bruggers J. Early Results of Orthopaedic Trauma and Anemia: Conservative Versus Liberal Transfusion Strategy. J Am Acad Orthop Surg. 2024 Mar 1;32(5):228-235. doi: 10.5435/JAAOS-D-23-00235. Epub 2023 Dec 27.

Reference Type: DERIVED

PMID: 38154083 (View on PubMed)

Mullis BH, Mullis LS, Kempton LB, Virkus W, Slaven JE, Bruggers J. Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study. J Orthop Trauma. 2024 Jan 1;38(1):18-24. doi: 10.1097/BOT.0000000000002696.

Reference Type: DERIVED

PMID: 38093439 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1402557771

Identifier Type: -

Identifier Source: org_study_id