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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000156-42-NL

Enrollment

Registered

2011-01-31

Start date

2011-04-19

Completion date

Unknown

Last updated

2018-01-29

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

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.

Interventions

Trade Name: Gelofusine Pharmaceutical Form: Intravenous infusion Trade Name: Hydroxyethylzetmeel (HES 130/0,4) Pharmaceutical Form: Intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Acute patiënts Redo operation Coagulation disorder Kidney failure

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective in this study is to examine if there is a difference in coagulation between Ringerlactaat/Gelofusine® priming and Ringerlactaat/HES 130/0.4 priming after coronary artery bypass graft (CABG), by measuring the thorax drain production on the intensive care. ;Secondary Objective: Also the effect at coagulation after a CABG procedure wille be examined by using the tromboelastography (rotation tromboealastometry, ROTEM; Pentapharm, München, Germany) and laboratory parameters;Primary end point(s): The thorax drain production after a CABG procedure will be examined after after 1, 3, 6, 12 hours on the intensive care. Also the total thorax drain will be examined on the intensive care	—

Measure

Time frame

Main Objective: The main objective in this study is to examine if there is a difference in coagulation between Ringerlactaat/Gelofusine® priming and Ringerlactaat/HES 130/0.4 priming after coronary artery bypass graft (CABG), by measuring the thorax drain production on the intensive care. ;Secondary Objective: Also the effect at coagulation after a CABG procedure wille be examined by using the tromboelastography (rotation tromboealastometry, ROTEM; Pentapharm, München, Germany) and laboratory parameters;Primary end point(s): The thorax drain production after a CABG procedure will be examined after after 1, 3, 6, 12 hours on the intensive care. Also the total thorax drain will be examined on the intensive care

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Countries

Netherlands

Outcome results

None listed

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