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Hemodilution and Coagulopathy With 3 Colloids

NCT ID: NCT01727830

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Dilutional Coagulopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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

Blood drawn from volunteers

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Theusinger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Anaesthesiology

Locations

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University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2012-0042

Identifier Type: -

Identifier Source: org_study_id