Amicar for Craniosynostosis Surgery

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's National Research Institute

Must not be taking: Anticoagulants

Disqualifiers: Coagulation disorder, Thrombotic event, Renal issues, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative period

22 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking anticoagulant medications like Coumadin, heparin, or aspirin, you will not be eligible to participate in this trial. The protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Amicar (ε-aminocaproic acid) for craniosynostosis surgery?

Research shows that Amicar (ε-aminocaproic acid) can reduce the amount of blood transfusions needed during craniosynostosis surgery, which is promising for its effectiveness and safety. Although it may not be as effective as another drug called tranexamic acid, Amicar is less expensive and has a lower risk of causing seizures. ^{1 2 3 4 5}

How does the drug Amicar differ from other treatments for craniosynostosis surgery?

Amicar (ε-aminocaproic acid) is unique in craniosynostosis surgery for its antifibrinolytic properties, which help reduce blood loss and the need for transfusions during surgery. Unlike other treatments, it specifically inhibits fibrinolysis (the breakdown of blood clots), making it effective in managing bleeding during complex cranial vault reconstruction. ^{1 4 6 7 8}

Research Team

Srijaya K Reddy, MD, MBA

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for children aged 2-36 months diagnosed with craniosynostosis requiring complex craniofacial reconstruction surgery. They must have parental consent to participate and no history of coagulation disorders, abnormal renal function, or prior thrombotic events. Children on anticoagulant therapy or with known hypersensitivity to Amicar are excluded.

Inclusion Criteria

My child has been diagnosed with craniosynostosis and needs surgery.

I am a child aged between 2 and 36 months.

Written informed consent from parent/guardian

Exclusion Criteria

I have a history of kidney abnormalities.

I have blood in my urine.

Subjects with a prior history of a thrombotic event

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Amicar or placebo during craniofacial reconstructive surgery to assess its efficacy in reducing blood loss

Intraoperative period

Immediate Postoperative Monitoring

Participants are monitored for blood loss and perioperative complications within the first 72 hours after surgery

72 hours

Follow-up

Participants are monitored for safety and effectiveness, including blood donor exposure, within the first 30 days after surgery

30 days

Treatment Details

Interventions

• Amicar (ε-aminocaproic acid)

Trial Overview The study tests if Amicar reduces blood loss during and after craniofacial surgery in children compared to a saline solution. The hypothesis suggests that patients receiving Amicar will need fewer blood transfusions perioperatively.

Participant Groups

Group I: Amicar (ε-aminocaproic acid) Experimental Treatment 1 Intervention

Treatment group 1: Amicar 100 mg/kg (0.4 mL/kg) IV loading dose, followed by an intraoperative continuous infusion at 40 mg/kg/hr (0.16 mL/kg/hr) to be continued until skin closure.

Group II: normal saline Placebo Group 1 Intervention

Treatment group 2: Equal volume of normal saline (placebo control) at the same rate as treatment group 1.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of epsilon-aminocaproic acid in infants undergoing craniofacial reconstruction surgery. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Epsilon Aminocaproic Acid's Safety and Efficacy in Pediatric Surgeries Including Craniosynostosis Repair: A Review of the Literature. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Spring-Mediated Cranioplasty in Sagittal Synostosis: Does Age at Placement Affect Expansion? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Minimizing transfusions in primary cranial vault remodeling: the role of aminocaproic acid. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Silicon membrane interpositioning for the prevention of skull deformity following experimental craniosynostosis. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Polyglycolic acid membrane interpositioning for the prevention of skull deformity following experimental craniosynostosis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of AMICAR on hemorrhagic complications of ECMO: a ten-year review. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

ε-Aminocaproic acid versus tranexamic acid in children undergoing complex cranial vault reconstruction for repair of craniosynostosis. [2022]