Study of Albumin to Reduce Inflammation Following Surgery

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether albumin administration during cardiac surgery is effective in attenuating the development of inflammation following surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• All patients over sixteen years of age undergoing surgery that requires cardiopulmonary bypass who provide informed written consent

Exclusion Criteria:

• Lack of informed consent

• Pregnancy

• Cyanotic congenital heart disease (due to high haemoglobin levels and increased haemolysis)

• Patients undergoing other extracorporeal interventions (ventricular assist devices, extracorporeal membrane oxygenators, pre-admission dialysis)

• Patients with congenital haemoglobinopathies (e.g. thalassaemia, cryoglobinuria, etc)

• Patients 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 gelofusine or human albumin solution

• Patients with an additive EUROSCORE of 10 or more