The effect of different solvents of HES preparations on coagulation and platelet function (Effekt der Trägerlösung von HES Präparaten auf Blutgerinnung und Thrombozytenfunktion)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002122-30-AT

Enrollment

Registered

2007-08-22

Start date

2007-09-14

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

treatment and prophylaxis of acute hypovolaemia and shock acute normovolaemic haemodilution MedDRA version: 9.1 Level: LLT Classification code 10021139 Term: Hypovolemia MedDRA version: 9.1 Level: HLGT Classification code 10011954 Term: Decreased and nonspecific blood pressure disorders and shock MedDRA version: 9.1 Level: LLT Classification code 10059489 Term: Hemodilution

Interventions

Trade Name: Vitafusal 6% Pharmaceutical Form: Intravenous infusion Trade Name: Venofundin 6% Infusionslösung Pharmaceutical Form: Intravenous infusion Trade Name: HAES-steril Fresenius (Haes 200/0,5

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: male ASA I age >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: female allery to HES products body mass index > 25kg/m2 smoking cardiovascular, renal, liver disease coagulation disorder blood group 0

Design outcomes

Primary

Measure	Time frame
Main Objective: to show that hes(hydroxyethylstarch) preparations in a balanced solution inhibit coagulation and platelet function less than conventional, unbalanced hes products;Secondary Objective: ;Primary end point(s): inhibiton of coagulation and platelet function tested with blood impedance aggregometry, ROTEM and flow cytometry	—

Countries

Austria

Outcome results

None listed

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