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
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
n/a
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05148650 -
Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers
|
N/A |