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Tranexamic Acid for Craniofacial Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Tranexamic Acid   Placebo
STARTED   9   11 
COMPLETED   9   11 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Tranexamic Acid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 9   11   20 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants 		     
Female      3  33.3%      5  45.5%      8  40.0% 
Male      6  66.7%      6  54.5%      12  60.0% 


  Outcome Measures

1.  Primary:   Total Volume (ml/kg) of Allogeneic Blood Exposure.   [ Time Frame: intraoperative and postoperative (24 hr) ]
  Show Outcome Measure 1

2.  Primary:   Number of Patients That Remained Transfusion Free   [ Time Frame: 24 hours ]
  Show Outcome Measure 2

3.  Secondary:   Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).   [ Time Frame: (baseline, after osteotomies, and immediately after procedure) ]
  Show Outcome Measure 3

4.  Secondary:   Platelets   [ Time Frame: baseline, after osteotomies, immediately after surgery ]
  Show Outcome Measure 4


  Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
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

Serious Adverse Events
    Tranexamic Acid   Placebo
Total, Serious Adverse Events     
# participants affected / at risk   0/9 (0.00%)   0/11 (0.00%) 




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated because two studies published during the trial demonstrated efficacy of tranexamic acid at a lower dose.


  More Information

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
e-mail: cladfp@upmc.edu


Publications:


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