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Tranexamic Acid for Craniofacial Surgery

This study has been terminated.
(Study dose changed based on recent publications)
Sponsor:
Information provided by (Responsible Party):
Franklyn Cladis, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00722436
First received: July 23, 2008
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: September 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Conditions: Craniosynostosis
Bleeding
Interventions: Drug: Tranexamic acid
Drug: saline

  Participant Flow
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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
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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
  Show All Outcome Measures

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

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

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) ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
Study First Received: July 23, 2008
Results First Received: September 16, 2016
Last Updated: February 10, 2017