Scavenging free haemoglobin atenuates the systemic inflmmatory response following surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004856-35-GB

Enrollment

540

Registered

2008-03-26

Start date

2008-03-17

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Zenalb 20% Product Name: Zenalb 20% Human albumin solution Pharmaceutical Form: Intravenous infusion Other descriptive name: HUMAN ALBUMIN SOLUTION Concentration unit: % (W/V) percent weig

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026