Hemodilution and Coagulopathy With 3 Colloids

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01727830

Enrollment

Registered

2012-11-16

Start date

2012-06-30

Completion date

2012-11-30

Last updated

2012-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilutional Coagulopathy

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

Interventions

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

Blood drawn from volunteers

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Reversibility of in vitro induced coagulopathy	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026