Scavenging free haemoglobin atenuates the systemic inflmmatory response following surgery

Phase 1

Active, not recruiting

• Conditions: Systemic inflammatory response and associated multiorgan failure that follows cardiopulmonary bypass for cardiac surgery; MedDRA version: 9.1Level: LLTClassification code 10062357Term: SIRS; MedDRA version: 9.1Level: LLTClassification code 10066123Term: Cardiopulmonary bypass; MedDRA version: 9.1Level: LLTClassification code 10018910Term: Haemolysis; MedDRA version: 9.1Level: LLTClassification code 10027803Term: MOF

• Registration Number: EUCTR2007-004856-35-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-26
• Study Completion: 2011-05-02
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

All patients over 16 years of age undergoing CPB for elective cardiac surgery at the Royal Brompton Hospital, London

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lack of informed consent
Pregnancy
Cyanotic congenital heart disease (high haematocrit increases haemolysis)
Patients undergoing other extracorporeal interventions (ECMO, VAD, pre-admission dialysis)
Patients with congenital haemoglobinopathies (e.g. thalassaemia, cryoglobinuria)
Ppatients with disorders of iron metabolism (e.g. haemochromatosis)
Religious objections to transfusion of a plasma derived product
Patients with known blood borne infection.
Patients with known hypersensitivity to human albumin solution or gelofusine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether administration of human albumin solution in the cardiopulmonary bypass prime solution will reduce free haem and free haemoglobin following cardiac surgery thereby reducing inflammation, organ dysfunction, and length of stay on the intensive care unit;Secondary Objective: ;Primary end point(s): Length of stay on the Intensive Care Unit