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The goal of the study is to improve the patients prognostif by decreasing perioperative blood losses thanks to two new colloidal solutions (last generation starches extracted from corn or potato) and thanks to an optimisation of the vascular filling by a low invasive monitoring: the vigileo.

Prospective, controled, randomized, double blind monocentric study evaluating the efficacy of the basic component of colloids (corn versus potato) on perioperative blood losses in elective cardiac surgery. - Tetrastarches

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005920-16-BE
Enrollment
Unknown
Registered
2012-01-11
Start date
2012-02-06
Completion date
Unknown
Last updated
2015-11-16

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

Conditions

Elective cardiac surgery

Interventions

Trade Name: PlasmaVolume Redibag 6% 500 ml Product Name: PlasmaVolume Redibag 6% 500ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: POTATO STARCH CAS Number: 8000006-02-2 Current Sp

Sponsors

Association Hospitalière CHU Brugmann
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients over the age of 18 years - Patients with an elective cardiac surgery, except emergency 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 81 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

Exclusion criteria: - Patients with an ASA class >3 - Cardiac decompression (HYHA class > III) - Cardiac aryhtmies - Significant aortic regurgitation - Coagulation alteration: platelet count 1,5 ; TCA > normal values) - Pre-existing renal insufficience (seric creatinin > 2 mg/ml) or oligo-anury, or hemodyalised patient - Hepatic function alteration (AST and ALT > two times the normal value) - Pregnancy - Surgical emergency

Design outcomes

Primary

MeasureTime frame
Main Objective: Security of hydroxyethyl starches;Secondary Objective: Security and efficacy of hydroxyethyl starches;Primary end point(s): Measure and calculation of blood losses;Timepoint(s) of evaluation of this end point: 48 h—

Secondary

MeasureTime frame
Secondary end point(s): - Creatinine clearance measure - Fluid balance measure - Volemic expansion measure - Other measures: gazometry, ionomerty, renal function, hemostasis, need of blood products, length of stay in intensive care, hospitalisation length, eventual side effects.;Timepoint(s) of evaluation of this end point: 48 h—

Countries

Belgium

Contacts

Public ContactAnesthesiology Department

CHU Brugmann

Philippe.VANDERLINDEN@chu-brugmann.be32024773996

Outcome results

None listed

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