Efficacy of ε-Aminocaproic Acid (EACA) in Children Undergoing Craniofacial Reconstruction Surgery

PRO00004263

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 hypothesize that Amicar will decrease intraoperative blood loss and decrease the need for perioperative blood product administration in children undergoing craniofacial surgery.

2014-10-01

2025-01-01

2025-03-01

Active (not recruiting)

Early phase I

22

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2023-09-01