Fibrinogen concentrate supplementation in the management of bleeding during paediatric cardiopulmonary bypass: a phase 1B/2A, open label dose escalation study (Version 1.0, Jan 28, 2014) - FIBCON: Fibrinogen concentrate in paediatric cardiopulmonary bypass

Guy's and St Thomas NHS Foundation Trust0 个研究点开始时间: 2014年2月14日最近更新: 2017年4月3日

试验速览

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•i) Congenital heart disease requiring non-emergency* surgery on cardiopulmonary bypass
•ii) Age range: > 36 weeks corrected gestation
•iii) Weight 2.5 – 12 kg
•iv) Informed consent to participate
•*Non-emergency is defined as surgery that can be delayed >24 hours following diagnosis of congenital heart disease
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•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

•i) Known pre-existing inherited coagulopathy
•ii) Known pre-existing inherited thrombophilia
•iii) Recent, acute (within previous 2 weeks) thrombosis in a major vessel or thrombotic-related major complications (as defined in sections 2.43 and 7.3)
•iv) Administration of antiplatelet agents (e.g. aspirin) <48 hrs prior to surgery
•v) Known hypersensitivity / allergy to study drug or similar products
•vi) History of anaphylaxis
•vii) Enrolment in another clinical trial in the previous 3 months
•viii) Parent/guardian unable to provide informed consent (this can include insufficient understanding of the trial, as judged by the clinician taking consent)
•ix) major co-morbidity likely to increase risk of mortality from surgical procedure
•x) significant renal/liver impairment within 2 days of planned surgery (creatinine > 2x ULN, ALT > 2x ULN)

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