Trial Outcomes & Findings for Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA (NCT NCT03631355)
NCT ID: NCT03631355
Last Updated: 2021-02-24
Results Overview
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Post-operative week 1
Results posted on
2021-02-24
Participant Flow
Participant milestones
| Measure |
ACL Reconstruction w/ BTB Autograft + IV TXA
Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
|
ACL Reconstruction w/ BTB Autograft, no IV TXA
Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
ACL Reconstruction w/ BTB Autograft + IV TXA
Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
|
ACL Reconstruction w/ BTB Autograft, no IV TXA
Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ACL Reconstruction w/ BTB Autograft + IV TXA
n=55 Participants
Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
|
ACL Reconstruction w/ BTB Autograft, no IV TXA
n=55 Participants
Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 5.8 • n=55 Participants
|
29.7 years
STANDARD_DEVIATION 8.5 • n=55 Participants
|
29.1 years
STANDARD_DEVIATION 7.3 • n=110 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=55 Participants
|
20 Participants
n=55 Participants
|
45 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=55 Participants
|
35 Participants
n=55 Participants
|
65 Participants
n=110 Participants
|
|
Meniscal Repair (Yes, No)
Meniscal Repair (Yes)
|
15 Participants
n=55 Participants
|
14 Participants
n=55 Participants
|
29 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
55 participants
n=55 Participants
|
55 participants
n=55 Participants
|
110 participants
n=110 Participants
|
|
Body Mass Index (kg/m^2)
|
26.8 kg/m^2
STANDARD_DEVIATION 5.2 • n=55 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 5.2 • n=55 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 5.2 • n=110 Participants
|
|
Operative Knee (Right, Left)
Operative Knee (Right)
|
34 Participants
n=55 Participants
|
29 Participants
n=55 Participants
|
63 Participants
n=110 Participants
|
|
Operative Knee (Right, Left)
Operative Knee (Left)
|
21 Participants
n=55 Participants
|
26 Participants
n=55 Participants
|
47 Participants
n=110 Participants
|
|
Meniscal Repair (Yes, No)
Meniscal Repair (No)
|
40 Participants
n=55 Participants
|
41 Participants
n=55 Participants
|
81 Participants
n=110 Participants
|
|
Meniscectomy (Yes, No)
Meniscectomy (Yes)
|
24 Participants
n=55 Participants
|
23 Participants
n=55 Participants
|
47 Participants
n=110 Participants
|
|
Meniscectomy (Yes, No)
Meniscectomy (No)
|
31 Participants
n=55 Participants
|
32 Participants
n=55 Participants
|
63 Participants
n=110 Participants
|
PRIMARY outcome
Timeframe: Post-operative week 1Population: The patients in each respective arm were evaluated for knee joint hemarthrosis and prompted joint aspiration because of pain or significant swelling.
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
Outcome measures
| Measure |
ACL Reconstruction w/ BTB Autograft + IV TXA
n=23 Participants
Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
|
ACL Reconstruction w/ BTB Autograft, no IV TXA
n=26 Participants
Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
|
|---|---|---|
|
POST-OPERATIVE HEMARTHROSIS
|
26.7 ml
Standard Deviation 23.1
|
37.3 ml
Standard Deviation 23.2
|
PRIMARY outcome
Timeframe: Days 1-7Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
Outcome measures
| Measure |
ACL Reconstruction w/ BTB Autograft + IV TXA
n=54 Participants
Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
|
ACL Reconstruction w/ BTB Autograft, no IV TXA
n=53 Participants
Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
|
|---|---|---|
|
POST-OPERATIVE Opioid Consumption
|
130.9 MME
Standard Deviation 90.9
|
113.9 MME
Standard Deviation 85.0
|
PRIMARY outcome
Timeframe: Post-operative day 7Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.
Outcome measures
| Measure |
ACL Reconstruction w/ BTB Autograft + IV TXA
n=54 Participants
Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
|
ACL Reconstruction w/ BTB Autograft, no IV TXA
n=53 Participants
Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid
|
|---|---|---|
|
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
|
2.7 score on a scale
Standard Deviation 1.9
|
3.2 score on a scale
Standard Deviation 1.8
|
Adverse Events
ACL Reconstruction w/ BTB Autograft + IV TXA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ACL Reconstruction w/ BTB Autograft, no IV TXA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael J. Alaia
NYU Langone Health Orthopedic Hospital
Phone: 6465017223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place