The Effectiveness and Population Pharmacokinetics and Pharmacogenomics of a Reduced Dose of Tranexamic Acid for Craniosynostosis Surgery: A multicenter study. The TXA Study. - Low dose tranexamic acid for craniosynostosis surgery

IRCCS Istituto Giannina Gaslini0 个研究点目标入组 60 人开始时间: 2014年9月29日最近更新: 2018年3月5日

试验速览

暂无简介。

•- 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any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn at any time without prejudice to child’s future medical care.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

•- 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.

发起方

IRCCS Istituto Giannina Gaslini