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Tranexamic Acid for Craniofacial Surgery

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ClinicalTrials.gov Identifier: NCT00722436
Recruitment Status : Terminated (Study dose changed based on recent publications)
First Posted : July 25, 2008
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Franklyn Cladis, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Craniosynostosis
Bleeding
Interventions Drug: Tranexamic acid
Drug: saline
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description

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.

Saline

saline: Placebo

Period Title: Overall Study
Started 9 11
Completed 9 11
Not Completed 0 0
Arm/Group Title Tranexamic Acid Placebo Total
Hide Arm/Group Description

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.

Saline

saline: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
<=18 years
9
 100.0%
11
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
3
  33.3%
5
  45.5%
8
  40.0%
Male
6
  66.7%
6
  54.5%
12
  60.0%
1.Primary Outcome
Title Total Volume (ml/kg) of Allogeneic Blood Exposure.
Hide Description 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.
Time Frame intraoperative and postoperative (24 hr)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

Saline

saline: Placebo

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: ml/kg
16.1  (13.9) 17.1  (10.4)
2.Primary Outcome
Title Number of Patients That Remained Transfusion Free
Hide Description [Not Specified]
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

Saline

saline: Placebo

Overall Number of Participants Analyzed 9 11
Measure Type: Number
Unit of Measure: participants
2 0
3.Secondary Outcome
Title Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
Hide Description [Not Specified]
Time Frame (baseline, after osteotomies, and immediately after procedure)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

Saline

saline: Placebo

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: seconds
PT -baseline 15.1  (0.84) 13.8  (0.74)
PT-after osteotomies 18.5  (3.93) 16.1  (1.94)
PT-immediately after surgery 17.7  (1.18) 17  (1.74)
PTT -baseline 34.6  (2.92) 32.9  (2.67)
PTT-after osteotomies 37.2  (9.75) 34.6  (3.62)
PTT-immediately after surgery 33.3  (3.5) 34.8  (3.9)
4.Secondary Outcome
Title Platelets
Hide Description [Not Specified]
Time Frame baseline, after osteotomies, immediately after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:

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.

Saline

saline: Placebo

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: 10^9 platelets/L
platelets-baseline 301  (109) 364  (125)
platelets-after osteotomies 253  (101) 300  (107)
platelets-immediately after surgery 223  (89) 231  (99)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description

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.

Saline

saline: Placebo

All-Cause Mortality
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Study terminated because two studies published during the trial demonstrated efficacy of tranexamic acid at a lower dose.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Franklyn Cladis
Organization: The Childrens Hospital of Pittsburgh of UPMC
Phone: 412-692-5260
Responsible Party: Franklyn Cladis, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00722436     History of Changes
Other Study ID Numbers: PRO07120134
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: September 16, 2016
Results First Posted: February 15, 2017
Last Update Posted: February 15, 2017