Hemodilution and Coagulopathy With 3 Colloids
|ClinicalTrials.gov Identifier: NCT01727830|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 16, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Dilutional Coagulopathy||Other: Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Observational Model:||Case Control|
|Official 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|
|Study Start Date :||June 2012|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
Other: Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
- This trial is in vitro and made with blood of healthy volunteers.
- Thus no drug no intervention beside drawing blood is beeing performed.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727830
|University Hospital Zurich, Division of Anaesthesiology|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Oliver Theusinger, MD||University Hospital Zurich, Division of Anaesthesiology|