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ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion (ORACL)

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ClinicalTrials.gov Identifier: NCT02972593
Recruitment Status : Enrolling by invitation
First Posted : November 23, 2016
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Atlanta Medical Center
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Brian Mullis, Indiana University

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).

Condition or disease Intervention/treatment Phase
Anemia Biological: Blood and blood products for transfusion Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Study Start Date : March 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Liberal
Blood and blood products for transfusion. Transfusion will be done to keep Hgb >7 g/dL.
Biological: 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.

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




Primary Outcome Measures :
  1. postoperative wound infection (superficial or deep) or other perioperative infection, information collected via subject questionnaire or record review [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Instances of Grade 3 Through Grade 5 Adverse Events Deemed Related to Transfusion, Graded According to NCI CTCAE Version 4.0, will be collected via subject questionnaire or record review [ Time Frame: one year ]
    Complications to be reported: pulmonary embolism, deep venous thrombosis, acute renal failure/insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia/infarct, pancreatitis, or death)

  2. musculoskeletal functional assessment questionnaire [ Time Frame: one year ]
    A 101 item questionnaire to provide information on daily functioning



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972593


Sponsors and Collaborators
Indiana University
Atlanta Medical Center
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Brian H Mullis, MD Indiana University

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Responsible Party: Brian Mullis, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT02972593     History of Changes
Other Study ID Numbers: 1402557771
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases