Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT02229968
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
36 Months
Study:
NCT02229968
Study Brief:
Protocol Section:
NCT02229968