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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the first 72 hours after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My child has been diagnosed with craniosynostosis and needs surgery.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intraoperative blood loss

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

210 Previous Clinical Trials

207,735 Total Patients Enrolled

Srijaya K Reddy, MD, MBAPrincipal InvestigatorVanderbilt University Medical Center

1 Previous Clinical Trials

Media Library

Amicar (ε-aminocaproic acid) (Antifibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT02229968 — Phase 2

Craniosynostosis Research Study Groups: Amicar (ε-aminocaproic acid), normal saline

Craniosynostosis Clinical Trial 2023: Amicar (ε-aminocaproic acid) Highlights & Side Effects. Trial Name: NCT02229968 — Phase 2

Amicar (ε-aminocaproic acid) (Antifibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02229968 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To date, how many people have enrolled in this clinical trial?

"This study has completed recruitment and is no longer looking for participants. The trial was first posted on October 1st, 2014 with the most recent edit taking place on May 25th, 2022. If you are interested in other studies, there are 9 clinical trials actively recruiting patients with acrocephaly and 2 for Amicar (ε-aminocaproic acid)."

Answered by AI

Would this research be appropriate for adults over the age of 25?

"Children who meet the age criteria of 2-36 months may be eligible for this study. Out of the 12 total trials, 10 are designed specifically for patients under 18 years old."

Answered by AI

Are there any previous findings with Amicar (ε-aminocaproic acid)?

"ε-aminocaproic acid, or Amicar, is being researched in 2 active clinical trials. Out of these studies, none have reached Phase 3 yet. Although most of the research for this treatment is based in Nashville, Tennessee, there are 2 other sites running trials."

Answered by AI

Are there any available positions for volunteers in this clinical trial?

"Presently, this study is not looking for new patients to enroll. The clinical trial was first posted on October 1st, 2014 and was last updated on May 25th, 2022. There are other studies ongoing that may be of interest; 9 trials for acrocephaly and 2 for Amicar (ε-aminocaproic acid) are actively recruiting participants."

Answered by AI

Could I qualify to become a test subject for this experiment?

"This study aims to enrol 22 children with acrocephaly that fall between the ages of 2-36 months old. The most crucial inclusion criteria are as follows: a formal diagnosis of craniosynostosis in need of surgical intervention, male or female gender, and a planned surgery involving complex craniofacial reconstruction and craniotomy."

Answered by AI