Trial Outcomes & Findings for Oral vs. Intravenous TXA Study Proposal: TJA (NCT NCT02233101)
NCT ID: NCT02233101
Last Updated: 2017-11-28
Results Overview
Patient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
during or within 24 hours after surgery
Results posted on
2017-11-28
Participant Flow
Participant milestones
| Measure |
Oral Tranexamic Acid
Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement
|
Intravenous Tranexamic Acid
Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
81
|
|
Overall Study
COMPLETED
|
74
|
80
|
|
Overall Study
NOT COMPLETED
|
12
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral vs. Intravenous TXA Study Proposal: TJA
Baseline characteristics by cohort
| Measure |
Oral Tranexamic Acid
n=86 Participants
Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement
|
Intravenous Tranexamic Acid
n=81 Participants
Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative
|
Total
n=167 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
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
58 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during or within 24 hours after surgeryPatient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.
Outcome measures
| Measure |
Oral Tranexamic Acid
n=74 Participants
Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement
|
Intravenous Tranexamic Acid
n=80 Participants
Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative
|
|---|---|---|
|
Number of Participants Who Required Blood Transfusion
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, an expected average of no more than 30 daysAny other complications listed below: 1. DVT or PE 2. Return to the OR within 30 days 3. Re-admission within 30 days 4. Superficial infection 5. Deep infection 6. Periprosthetic fracture 7. Cerebrovascular accident or Transient ischemic attack 8. Dislocation
Outcome measures
| Measure |
Oral Tranexamic Acid
n=74 Participants
Patients will receive either oral or intravenous Tranexamic Acid
Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement
|
Intravenous Tranexamic Acid
n=80 Participants
Patients will receive either oral or intravenous Tranexamic Acid
Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative
|
|---|---|---|
|
Other Complications
|
0 participants
|
0 participants
|
Adverse Events
Oral Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Tranexamic Acid
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
Craig J. Della Valle, MD
Rush University Medical Center
Phone: 312-432-2350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place