Trial Outcomes & Findings for Tranexamic Acid for Craniofacial Surgery (NCT NCT00722436)
NCT ID: NCT00722436
Last Updated: 2017-02-15
Results Overview
This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
intraoperative and postoperative (24 hr)
Results posted on
2017-02-15
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group.
|
Placebo
Saline
saline: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tranexamic Acid for Craniofacial Surgery
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=9 Participants
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group.
|
Placebo
n=11 Participants
Saline
saline: Placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intraoperative and postoperative (24 hr)This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.
Outcome measures
| Measure |
Tranexamic Acid
n=9 Participants
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group.
|
Placebo
n=11 Participants
Saline
saline: Placebo
|
|---|---|---|
|
Total Volume (ml/kg) of Allogeneic Blood Exposure.
|
16.1 ml/kg
Standard Deviation 13.9
|
17.1 ml/kg
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Tranexamic Acid
n=9 Participants
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group.
|
Placebo
n=11 Participants
Saline
saline: Placebo
|
|---|---|---|
|
Number of Patients That Remained Transfusion Free
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: (baseline, after osteotomies, and immediately after procedure)Outcome measures
| Measure |
Tranexamic Acid
n=9 Participants
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group.
|
Placebo
n=11 Participants
Saline
saline: Placebo
|
|---|---|---|
|
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
PTT-immediately after surgery
|
33.3 seconds
Standard Deviation 3.5
|
34.8 seconds
Standard Deviation 3.9
|
|
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
PT -baseline
|
15.1 seconds
Standard Deviation 0.84
|
13.8 seconds
Standard Deviation 0.74
|
|
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
PT-after osteotomies
|
18.5 seconds
Standard Deviation 3.93
|
16.1 seconds
Standard Deviation 1.94
|
|
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
PT-immediately after surgery
|
17.7 seconds
Standard Deviation 1.18
|
17 seconds
Standard Deviation 1.74
|
|
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
PTT -baseline
|
34.6 seconds
Standard Deviation 2.92
|
32.9 seconds
Standard Deviation 2.67
|
|
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
PTT-after osteotomies
|
37.2 seconds
Standard Deviation 9.75
|
34.6 seconds
Standard Deviation 3.62
|
SECONDARY outcome
Timeframe: baseline, after osteotomies, immediately after surgeryOutcome measures
| Measure |
Tranexamic Acid
n=9 Participants
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr
Patients are randomized to TXA or saline. This group is the TXA group.
|
Placebo
n=11 Participants
Saline
saline: Placebo
|
|---|---|---|
|
Platelets
platelets-baseline
|
301 10^9 platelets/L
Standard Deviation 109
|
364 10^9 platelets/L
Standard Deviation 125
|
|
Platelets
platelets-after osteotomies
|
253 10^9 platelets/L
Standard Deviation 101
|
300 10^9 platelets/L
Standard Deviation 107
|
|
Platelets
platelets-immediately after surgery
|
223 10^9 platelets/L
Standard Deviation 89
|
231 10^9 platelets/L
Standard Deviation 99
|
Adverse Events
Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Franklyn Cladis
The Childrens Hospital of Pittsburgh of UPMC
Phone: 412-692-5260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place