EUCTR2007-004856-35-GB
Active, not recruiting
Phase 1
Scavenging free haemoglobin atenuates the systemic inflmmatory response following surgery
ConditionsSystemic inflammatory response and associated multiorgan failure that follows cardiopulmonary bypass for cardiac surgeryMedDRA version: 9.1Level: LLTClassification code 10062357Term: SIRSMedDRA version: 9.1Level: LLTClassification code 10066123Term: Cardiopulmonary bypassMedDRA version: 9.1Level: LLTClassification code 10018910Term: HaemolysisMedDRA version: 9.1Level: LLTClassification code 10027803Term: MOF
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Systemic inflammatory response and associated multiorgan failure that follows cardiopulmonary bypass for cardiac surgery
- Sponsor
- Imperial College London
- Enrollment
- 540
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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