CompletedPhase 1/2

Dilutional Coagulopathy in Patients Undergoing Elective Surgery

Denmark20 participantsStarted 2007-06

Plain-language summary

The purpose of the present study is to perform a comprehensive description of haemostasis parameters before and after haemodilution with Hydroxyethyl starch (HES) following acute bleeding during elective surgery. Moreover the study aims to test the in vivo haemostatic potential of fibrinogen concentrate in dilutional coagulopathy caused by HES in a clinical, prospective, placebo-controlled randomised setup. We hypothesise; a) A coagulopathy is induced following in vivo haemodilution; b) the coagulopathy is improved or partially improved by fibrinogen.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \> 18 years * Indication for performing cystectomia * Written informed consent Exclusion Criteria: * Uses of acetyl-salicylic or non-steroid anti-inflammatory drugs 2 days prior to blood sampling. * Abnormal preoperative coagulations parameters (Platelets, PP, APTT, D- dimer, Fibrinogen, AT, TT) * Disseminated cancer and/or bone metastasis * Medical history of ischemic heart disease, claudicatio, or arteriosclerosis * Medical history of previous thrombo-embolic event * Renal failure defined as clinical relevant abnormal levels of creatinine * Liver failure defined as clinical relevant abnormal levels of ALAT * Hypersensibility to Voluven, Haemocomplettan or ingredients * Fertile women not using safe contraception

What they're measuring

Dynamic whole blood clot formation.

Timeframe: 60 minutes

Trial details

NCT IDNCT00493272

SponsorChristian Fenger-Eriksen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-04

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