Trial Outcomes & Findings for ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion (NCT NCT02972593)
NCT ID: NCT02972593
Last Updated: 2023-06-29
Results Overview
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.
COMPLETED
PHASE4
161 participants
one year
2023-06-29
Participant Flow
Participants were recruited based on physician referral at 3 level 1 trauma centers between March 2014 and May 2021. The first patient was enrolled on March 11, 2014 and the last participant was enrolled on May 7, 2021.
Screening/IC done on 161 patients with a Hgb of ≤9g/dL or whose Hgb was expected to drop below 9g/dL with planned procedures/continued (controlled) bleeding. Randomization assignment occurred once patient's Hgb dropped below 7g/dL. Out of the 161 patient that consented, there were 61 whose Hgb did not drop below 7g/dL and randomization was not performed on. Those 61 patients were considered screen failures, leaving 100 patients who were randomized to either liberal or conservative transfusion.
Participant milestones
| Measure |
Liberal
Blood and blood products for transfusion. Transfusion will be done to keep Hgb \>7 g/dL.
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.
|
Conservative
Blood and blood products for transfusion. Transfusion will be done to keep Hgb \> 5.5 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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
30
|
35
|
|
Overall Study
NOT COMPLETED
|
20
|
15
|
Reasons for withdrawal
| Measure |
Liberal
Blood and blood products for transfusion. Transfusion will be done to keep Hgb \>7 g/dL.
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.
|
Conservative
Blood and blood products for transfusion. Transfusion will be done to keep Hgb \> 5.5 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
15
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Baseline characteristics by cohort
| Measure |
Liberal Transfusion
n=49 Participants
Transfusion will be done to keep Hgb \>7 g/dL.
|
Conservative Transfusion
n=50 Participants
Transfusion will be done to keep Hgb \> 5.5 g/dL.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
50 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearDeep 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.
Outcome measures
| Measure |
Liberal
n=49 Participants
Transfusion will be done to keep Hgb \>7 g/dL.
|
Conservative
n=50 Participants
Transfusion will be done to keep Hgb \> 5.5 g/dL.
|
|---|---|---|
|
Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection
|
12 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: one yearCombined (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.
Outcome measures
| Measure |
Liberal
n=49 Participants
Transfusion will be done to keep Hgb \>7 g/dL.
|
Conservative
n=50 Participants
Transfusion will be done to keep Hgb \> 5.5 g/dL.
|
|---|---|---|
|
Combined Secondary Outcomes
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Sixty five patients completed 1 year follow up but 5 declined to complete the MFA, leaving sixty patients that completed 1 year MFA.
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.
Outcome measures
| Measure |
Liberal
n=29 Participants
Transfusion will be done to keep Hgb \>7 g/dL.
|
Conservative
n=31 Participants
Transfusion will be done to keep Hgb \> 5.5 g/dL.
|
|---|---|---|
|
Musculoskeletal Function Assessment
|
35.9 score on a scale
Standard Deviation 21.1
|
28.2 score on a scale
Standard Deviation 19.4
|
Adverse Events
Liberal
Conservative
Serious adverse events
| Measure |
Liberal
n=49 participants at risk
Transfusion will be done to keep Hgb \>7 g/dL.
|
Conservative
n=50 participants at risk
Transfusion will be done to keep Hgb \> 5.5 g/dL.
|
|---|---|---|
|
Vascular disorders
Secondary DVT
|
4.1%
2/49 • Number of events 2 • 1 year
|
2.0%
1/50 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Transfusion-related acute lung injury (TRALI)
|
10.2%
5/49 • Number of events 5 • 1 year
|
10.0%
5/50 • Number of events 5 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian H. Mullis
Indiana University School of Medicine Department of Orthopaedic Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place