ow dose tranexamic acid for craniosynostosis surgery

Phase 1

• Conditions: craniosynostosis; MedDRA version: 17.0Level: PTClassification code 10049889Term: CraniosynostosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-001056-35-IT
• Lead Sponsor: IRCCS Istituto Giannina Gaslini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-29
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Infants and children, M or F, aged 3 months to 3 years, undergoing craniosynostosis repair, fronto-orbital advancement surgery and cranial remodeling surgery (i.e., total cavernal remodeling surgery);
- Parents’/guardian written informed consent given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn at any time without prejudice to child’s future medical care.

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Preexisting hematological abnormality (defined as a positive history of bleeding disorder or a known diagnosis of a genetic or acquired bleeding disorder);
- Preexisting coagulation defect (defined as PT, PTT or INR >1.5 times normal or a n pre-existing genetic or acquired coagulation defect);
- Preexisting hepatic, renal, vascular, ocular and/or metabolic disorder;
- History of acetylsalicylate administration within the last 14 days;
- History of NSAIDs administration with 2 days of the scheduled surgery date.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified