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Hemodilution and Coagulopathy With 3 Colloids

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ClinicalTrials.gov Identifier: NCT01727830
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 16, 2012
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin
U.S. FDA Resources


Intervention Details:
    Other: Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
    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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727830


Locations
Switzerland
University Hospital Zurich, Division of Anaesthesiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Oliver Theusinger, MD University Hospital Zurich, Division of Anaesthesiology

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01727830     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2012-0042
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders