Fibrinogen concentrate supplementation in the management of bleeding during paediatric cardiopulmonary bypass: a phase 1B/2A, open-label dose-escalation study

Guy's and St Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 111 人开始时间: 2014年5月1日最近更新: 2022年11月28日

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33213194/ results (added 23/11/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36371257/ mechanistic sub-study of the FIBCON trial (added 14/11/2022)

•1. Congenital heart disease requiring non-emergency* surgery on cardiopulmonary bypass
•2. Age range: >36 weeks corrected gestation
•3. Weight 2.5 to 12 kg
•4. Informed consent to participate
•*Non-emergency is defined as surgery that can be delayed >24 hours following diagnosis of congenital heart disease

•1. Known pre-existing inherited coagulopathy
•2. Known pre-existing inherited thrombophilia
•3. Recent, acute (within previous 2 weeks) thrombosis in a major vessel or thrombotic related major complications (as defined in protocol sections 2.43 and 7.3)
•4. Administration of antiplatelet agents (e.g. aspirin) <48 hours prior to surgery
•5. Known hypersensitivity/allergy to the study drug or similar products
•6. History of anaphylaxis
•7. Enrolment in another clinical trial in the previous 3 months
•8. Parent/guardian unable to provide informed consent (this can include insufficient understanding of the trial, as judged by the clinician taking consent)
•9. Major comorbidity likely to increase risk of mortality from surgical procedure
•10. Significant renal/liver impairment within 2 days of planned surgery (creatinine > 2x Upper Limit of Normal, Alanine Aminotransferase > 2x ULN)

发起方

Guy's and St Thomas' NHS Foundation Trust (UK)