Fibrinogen concentrate supplementation for infants undergoing heart surgery with cardiopulmonary bypass

Phase 1

Conditions: eonates and infants who are at risk of mediastinal bleeding following cardiopulmonary bypass surgery for congenital heart disease
MedDRA version: 16.1Level: LLTClassification code 10055817Term: Haemorrhage intrapericardialSystem Organ Class: 100000004849
MedDRA version: 16.1Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000004850
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2013-003532-68-GB

Lead Sponsor: Guy's and St Thomas NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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)