ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion

NCT02972593 | Completed Phase 4 Results DMC

• 1 other identifier: 1402557771
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection

  Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.

  one year

Secondary Outcomes (2)

• Combined Secondary Outcomes

  one year

• Musculoskeletal Function Assessment

  one year

Study Arms (2)

Liberal

OTHER

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

Biological: Blood and blood products for transfusion

Conservative

OTHER

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

Biological: Blood and blood products for transfusion

Interventions

Blood and blood products for transfusion 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; Liberal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Atlanta Medical Center: collaborator

Related Publications (2)

• 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.

  PMID: 38154083 DERIVED

• 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.

  PMID: 38093439 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Blood Specimen Collection; Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Therapy; Therapeutics

Limitations and Caveats

Significant loss to follow up; Significant resistance by multiple providers at each site to allow conservative treatment algorithm (as most felt liberal was standard of care); Slow enrollment; No funding

Results Point of Contact

• Title: Dr. Brian H. Mullis
• Organization: Indiana University School of Medicine Department of Orthopaedic Surgery

bmullis@iupui.edu

317-963-1966

Study Officials

• Brian H Mullis, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: March 1, 2014
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share