FIBCON: FIBrinogen CONcentrate in paediatric cardiopulmonary bypass

Phase 2

Completed

• Conditions: Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases; Surgery

• Registration Number: ISRCTN50553029
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-01
• Study Completion: 2016-03-02
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified