Status:
ACTIVE_NOT_RECRUITING
Efficacy of Amicar for Children Having Craniofacial Surgery
Lead Sponsor:
Children's National Research Institute
Conditions:
Craniosynostosis
Eligibility:
All Genders
2-36 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective in reducing blood loss in children undergoing craniofacial reconstruction surgery. The investigators hypoth...
Detailed Description
Craniosynostosis is a condition in which there is premature fusion of one or more of the sutures between the bones of the skull. Premature fusion of sutures in the skull limits the ability of the cran...
Eligibility Criteria
Inclusion
- Any child diagnosed with craniosynostosis in need of surgical repair
- Males and females between the ages of 2 - 36 months (minorities will be included)
- Surgical procedure involving complex craniofacial reconstruction and craniotomy
- Written informed consent from parent/guardian
Exclusion
- Subjects with known or suspected hypersensitivity reaction to Amicar or history of prior Amicar exposure
- Presence or prior history of a known coagulation disorder or hypercoagulable state
- Preoperative laboratory values that indicate clinically significant hematologic disease (hemoglobin, platelet count, prothrombin time, or partial thromboplastin time outside of normal range)
- Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)
- Subjects with a prior history of a thrombotic event
- History of renal malformation
- Presence of hematuria
- History of abnormal renal function - serum creatinine or blood urea nitrogen (BUN) value greater than 1.5 times the upper limit of the normal range
- Craniofacial reconstruction surgery performed in conjunction with an additional surgical procedure associated with blood loss
- Subjects who have been previously enrolled in this protocol may not be enrolled again
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02229968
Start Date
October 1 2014
End Date
March 1 2027
Last Update
February 11 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232