Trial Outcomes & Findings for Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty (NCT NCT02747615)
NCT ID: NCT02747615
Last Updated: 2020-09-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
48-72 hours after surgery.
Results posted on
2020-09-07
Participant Flow
Participant milestones
| Measure |
Control Group (n=30)
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
transfused only allogeneic blood.
|
Preoperative Blood Donation (n=30)
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
transfused pre-operatively donated autologous blood.
intravenous tranexamic acid (TXA) infusion
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group (n=30)
n=30 Participants
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
transfused only allogeneic blood.
|
Preoperative Blood Donation (n=30)
n=30 Participants
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
transfused pre-operatively donated autologous blood.
intravenous tranexamic acid (TXA) infusion
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 4.4 • n=30 Participants
|
67.4 years
STANDARD_DEVIATION 4.1 • n=30 Participants
|
67.6 years
STANDARD_DEVIATION 4.2 • n=60 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
25 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 48-72 hours after surgery.Outcome measures
| Measure |
Control Group (n=30)
n=30 Participants
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
transfused only allogeneic blood.
|
Preoperative Blood Donation (n=30)
n=30 Participants
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
transfused pre-operatively donated autologous blood.
intravenous tranexamic acid (TXA) infusion
|
|---|---|---|
|
Number of Transfused Allogeneic Blood Units (in Digits).
|
2.0 units
Interval 1.0 to 3.0
|
0.0 units
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 48-72 hours after surgery.Outcome measures
| Measure |
Control Group (n=30)
n=30 Participants
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
transfused only allogeneic blood.
|
Preoperative Blood Donation (n=30)
n=30 Participants
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
transfused pre-operatively donated autologous blood.
intravenous tranexamic acid (TXA) infusion
|
|---|---|---|
|
Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days).
|
5.27 days
Standard Deviation 1.11
|
3.20 days
Standard Deviation 0.41
|
Adverse Events
Control Group (n=30)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preoperative Blood Donation (n=30)
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. Ibrahim Mamdouh Esmat
Ain-Shams University Hospitals
Phone: 01001241928
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place