AnemiaPhase 4ORACLNCT02972593
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
A Phase 4 study testing Blood and blood products for transfusion in people with Anemia, run by Indiana University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anemia
- What is being tested?
- Blood and blood products for transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to 24 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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).
Read the 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
- Being tested
- Blood and blood products for transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and blood products for transfusionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Liberal | Other | Blood and blood products for transfusion. Transfusion will be done to keep Hgb >7 g/dL. Receives: 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. Receives: Biological: Blood and blood products for transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
Combined Secondary Outcomes
Combined (any) Secondary Outcomes: 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.
Measured: one year
Musculoskeletal Function Assessment
The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startMar 2014
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlanta Medical Center
- Responsible party
- Principal investigator, Brian Mullis, Indiana University
- Investigators
- Brian H Mullis, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972593
- Sponsor's protocol ID
- 1402557771
- Acronym
- ORACL
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2016
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38154083Mullis 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.
PubMed 38093439
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
- ClinicalTrials.gov ID
- NCT02972593
- Acronym / sponsor ID
- ORACL / 1402557771
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Atlanta Medical Center
- Study start
- Mar 2014 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal | Other | Biological: Blood and blood products for transfusionBlood and blood products for transfusion. Transfusion will be done to keep Hgb >7 g/dL. |
| Conservative | Other | Biological: Blood and blood products for transfusionBlood and blood products for transfusion. Transfusion will be done to keep Hgb > 5.5 g/dL. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and blood products for transfusionRandomization 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. | Biological | Conservative, Liberal |
Primary outcome
Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection
Time frame: one year
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.
2 secondary outcomes
Combined Secondary Outcomes
Time frame: one year
Musculoskeletal Function Assessment
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38154083Mullis 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.
- Derived from this study: PubMed 38093439Mullis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian H Mullis, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood and blood products for transfusion in people with Anemia, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972593, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.