Hemodilution and Coagulopathy With 3 Colloids

Dilutional Coagulopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727830
• Other study ID #: KEK-ZH-Nr. 2012-0042
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2012
• Last updated: November 12, 2012
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Dilutional Coagulopathy
• Hemostatic Disorders

Intervention

Other:
• Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)
Blood drawn from volunteers

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Anaesthesiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversibility of in vitro induced coagulopathy	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.	Same day when blood was drawn	Yes