Hemodilution and Coagulopathy With 3 Colloids

NCT01727830 | Completed

• 1 other identifier: KEK-ZH-Nr. 2012-0042
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Dilutional Coagulopathy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Blood drawn from volunteers

Also known as: 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

volunteers

You may qualify if:

• signed informed consent from before blood withdrawal

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Gelatin; physiogel; In Vitro Techniques

Intervention Hierarchy (Ancestors)

Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins; Investigative Techniques

Study Officials

• Oliver Theusinger, MD

  University Hospital Zurich, Division of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 16, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

CH (1)