Hemodilution and Coagulopathy With 3 Colloids

University of Zurich (UZH)

Status: Completed

Conditions: Dilutional Coagulopathy

Treatments: Other: Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)

Study type: Observational

Funder types: Other

Identifiers

NCT01727830

KEK-ZH-Nr. 2012-0042

Details and patient eligibility

About

Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII.

In blood of 12 volunteers the following measurements are performed at baseline and 60% dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and determination of factor concentrations are again performed.

• Trial with medical device

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• signed informed consent from before blood withdrawal

Exclusion criteria

• known coagulation disorders,
• any form of anticoagulation therapy,
• use of acetyl-salicylic acid within the past five days,
• use of non-steroidal anti-inflammatory agents within the past 24 hours,
• known renal disease or plasma concentrations of aspartate aminotransferase (>50 U l -1) or alanine aminotransferase (>50 U l-1)
• patients incapable of understanding the German language