Can a simple drug cut blood loss in Kids' skull surgery?
NCT ID NCT02229968
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a medicine called Amicar (EACA) can reduce blood loss in children aged 2 to 36 months who need skull reconstruction for a condition called craniosynostosis. The trial involves 22 children, half receiving Amicar and half receiving a placebo (salt water). The goal is to see if Amicar decreases bleeding during surgery and reduces the need for blood transfusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amicar (epsilon-aminocaproic acid)
- What this could lead to
- If it works, this could provide a way to reduce blood loss and the need for blood transfusions in young children undergoing skull surgery.
- What could go wrong
- This is a small, early-phase trial with only 22 children, so results may not apply broadly. The drug may not significantly reduce blood loss or could cause side effects like allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
22 people
The number who actually took part.
- Start date
-
Oct 2014
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 to 36 months
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.