Efficacy of Amicar for Children Having Craniofacial Surgery (NCT02229968) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy of Amicar for Children Having Craniofacial Surgery
United States22 participantsStarted 2014-10
Plain-language 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 hypothesize that Amicar will decrease intraoperative blood loss and decrease the need for perioperative blood product administration in children undergoing craniofacial surgery.
Who can participate
Age range
2 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative blood loss
Timeframe: within the first 72 hours after surgery