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Antifibrinolytic agent

Amicar for Craniosynostosis Surgery

Phase 2

Waitlist Available

Led By Srijaya K Reddy, MD, MBA

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any child diagnosed with craniosynostosis in need of surgical repair

Surgical procedure involving complex craniofacial reconstruction and craniotomy

Must not have

History of renal malformation

Presence of hematuria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the first 72 hours after surgery

Summary

This trial will test whether Amicar reduces blood loss and the need for blood transfusions in children undergoing craniofacial surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Amicar may include allergic reactions for those sensitive to the drug, increased risk of clotting due to its action on bleeding processes, and possible negative effects on kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child has been diagnosed with craniosynostosis and needs surgery.

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I am scheduled for or have had surgery on my skull and face.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of kidney abnormalities.

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I have blood in my urine.

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I had surgery on my skull or face that was done with another surgery where I lost blood.

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I have or had a blood clotting disorder.

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I am currently taking blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within the first 72 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within the first 72 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first 72 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraoperative blood loss

Secondary study objectives

Blood donor exposure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Amicar (ε-aminocaproic acid)Experimental Treatment1 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 salinePlacebo Group1 Intervention

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

0 / 7Eligibility criteria met