Skip to main content
OpenTrials
Completed

NCT Number: NCT01727830

Hemodilution and Coagulopathy With 3 Colloids

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dilutional Coagulopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)

Other

Blood drawn from volunteers

Other names: This trial is in vitro and made with blood of healthy volunteers., Thus no drug no intervention beside drawing blood is beeing performed.

Primary outcomes

  1. Reversibility of in vitro induced coagulopathy

    Time frame: Same day when blood was drawn

    Coagulopathy in vitro measured after 60 % dilution with HES, Gelatin and Gelatin balanced. Addition of fibrinogen and factor XIII as well as their combination and measurement if the coagulopathy was corrected.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Influence of Hemodilution on Coagulation, pH, Platelet Function, Laboratory Values and ROTEM in Volunteers Using HES 6%, Gelatine and Balanced Gelatine and the Reversal of Coagulopathy With F XIII and Fibrinogen

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2012
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.