Hemodilution and Coagulopathy With 3 Colloids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01727830
First received: November 5, 2012
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Dilutional Coagulopathy
Other: Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Reversibility of in vitro induced coagulopathy [ Time Frame: Same day when blood was drawn ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 12
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01727830     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2012-0042
Study First Received: November 5, 2012
Last Updated: November 12, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on August 27, 2014