Effect of the plasma substitutes Gelofusine and Hydroxyethyl Starch 130/0.4 combined with lactated ringer's solution on the coagulation system - Effect of plasma substitutes on the coagulation system

Phase 1

• Conditions: A standard component of the priming which is used in extra corporal circulation is the synthetic colloïd Gelofusine (Braun, Melsung AG, Germany). Because of logistical reasons and cost saving the question is arised if Gelofusine can be replaced by the synthetic colloïd Hydroxyethyl Starch (HES) 130.04 (Fresenius Kabi). In this RCT will be examined if Gelofusine can be replaced by HES by examinating post operative thorax drains production in intensive care.

• Registration Number: EUCTR2011-000156-42-NL
• Lead Sponsor: Amphia Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

elective coronary artery bypass grafts procedures
age 18-85 year
Hb > 8.4 mmol/l

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

Acute patiënts
Redo operation
Coagulation disorder
Kidney failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified