Comparison of Albumin 5%, Hydroxyethyl Starch 130/0.4 (6%) and Ringer Lactate for volume replacement during cardiac surgery - n/a

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005040-85-AT

Enrollment

240

Registered

2006-02-01

Start date

2006-03-17

Completion date

Unknown

Last updated

2013-11-04

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

Conditions

Intensive care patients after cardiac surgery requiring volume therapy

Interventions

Trade Name: Human Albumin 'Immuno' 5% Product Name: Human Albumin 'Immuno' 5% Product Code: n/a Pharmaceutical Form: Solution for infusion Trade Name: Voluven (HES 130/0,4) 6% - Infusionslösung Produ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing elective cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG), valve repair or replacement, and Aorta ascendens surgery 2) Age > 18 years 3) Written informed consent obtained 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: 1) Known allergy to Hydroxyethyl starch or Albumin 2) Aspirin use less than 3 days before surgery 3) GPIIbIIIa antagonists use less than 7 days before surgery 4) Coagulation disorders (INR > 1.2, aPTT > 40sec, platelet count 40 6) Left ventricular ejection fraction 1.5mg/dl 8) Proven heparin induced thrombocytopenia (Danaparoid, Lepirudin use less than 1 month) 9) Deny of consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin, HES 130/0.4, and Ringer Lactate. The main outcome parameter is the cumulative volume of mediastinal blood loss 24 hours after cardiopulmonary bypass.;Secondary Objective: Laboratory parameters • Hemoglobin concentration (Hb) • Prothrombin time (PTT) • Hb of mediastinal blood loss • ROTEG Analysis: .The ROTEG analyses will be performed on a Rotational Thromboelastograph (ROTEG, Pentapharm, Munich, Germany) and the samples will be analyzed 120 seconds after the blood was drawn from the intravenous catheter. Both INTEG and EXTEG analyses will be performed according to standard procedure recommended by the manufacturer. o Clotting Time (CT) reflecting the initiation of the coagulation, o Clot Formation Time (CFT) reflecting the rate of clot formation o A15 describing the strength of the clot 15 minutes after initiation of the coagulation • pH-value, pCO2, BE, Lactate, Serum Kreatinin • volume of study drug • fluid balance POD 1 and 2 • reoperation caused by bleeding • duration of intubation, reintubation • length of intensive care unit stay • blood product use • 30 days mortality;Primary end point(s): Cumulative volume of mediastinal blood loss 24 hours after cardiopulmonary bypass	—

Measure

Time frame

Main Objective: The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin, HES 130/0.4, and Ringer Lactate. The main outcome parameter is the cumulative volume of mediastinal blood loss 24 hours after cardiopulmonary bypass.;Secondary Objective: Laboratory parameters • Hemoglobin concentration (Hb) • Prothrombin time (PTT) • Hb of mediastinal blood loss • ROTEG Analysis: .The ROTEG analyses will be performed on a Rotational Thromboelastograph (ROTEG, Pentapharm, Munich, Germany) and the samples will be analyzed 120 seconds after the blood was drawn from the intravenous catheter. Both INTEG and EXTEG analyses will be performed according to standard procedure recommended by the manufacturer. o Clotting Time (CT) reflecting the initiation of the coagulation, o Clot Formation Time (CFT) reflecting the rate of clot formation o A15 describing the strength of the clot 15 minutes after initiation of the coagulation • pH-value, pCO2, BE, Lactate, Serum Kreatinin • volume of study drug • fluid balance POD 1 and 2 • reoperation caused by bleeding • duration of intubation, reintubation • length of intensive care unit stay • blood product use • 30 days mortality;Primary end point(s): Cumulative volume of mediastinal blood loss 24 hours after cardiopulmonary bypass

—

Countries

Austria

Outcome results

None listed

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