Fluid replacement with colloids and its impact on platelets, hemostasis and renal function

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004452

Enrollment

Registered

2012-10-30

Start date

2012-02-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E86 P74.1 R57 T81.1 T79.4

Interventions

Group 1: Human Albumin (Human Albumin) from "Biotest"® 5% in normal saline (elektrolyte concentration in mmol/l: sodium 154, chloride 154) intravenous infusion of 30ml/kg over 120 minutes. Group 2:

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: male ASA-Classification I Age > 18 and < 65 no medication intake no renal function disease

Exclusion criteria

Exclusion criteria: blood group 0, liver disease, hematological disease, BMI over 25kg/m2, allergy

Design outcomes

Primary

Measure	Time frame
Three currently available kolloids will be analysed for its impact on platelet function. Poweranalysis was performed based on the ADP induced aggregation Area under the Curve - AUC in Multiple Electrode Aggregometry (MEA). Differences in aggregation before and after infusion will be analysed in all three groups. Changes under 12 units are set equally.	—

Secondary

Measure	Time frame
All other parameters will be analysed before and after the infusion. These are other hemostasis parameters from ROTEM and renal function test parameters.	—

Countries

Austria

Contacts

Public ContactLéonore Wetzel

Medizinische Universität Wien, Abteilung für Allgemeine Anästhesie, Intensivmedizin und Schmerztherapie

leonore.wetzel@meduniwien.ac.at00431404004100

Outcome results

None listed

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