Hydroxyethylstarch induced coagulopathy and haemostatic potential of fibrinogen - in vivo placebo controlled clinical trial.
- Conditions
- The present study evaluates dilution coagulopathy induced by hydroxyethyl starch solutions in a clinical setting on patients undergoeing cystektomia due to bladder cancer. Furteher the haemostatic effect of fibrinogen concentrate is evaluated by randomised infusion following haemodilution.MedDRA version: 9.1Level: PTClassification code 10060906Term: Dilutional coagulopathyMedDRA version: 9.1Level: LLTClassification code 10016595Term: Fibrinogen
- Registration Number
- EUCTR2007-000026-44-DK
- Lead Sponsor
- Aarhus Universityhospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
•> 18 år
•Indication for cystektomia
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Anticoagulant treatment and use of acetylsalicyclic acid and/or NSAID within 2 days.
•Abnormale preoperative coagulationsparametres (Thr, PP, APTT, D-dimer, Fibrinogen, AT, TT)
•Disseminated cancer and/or metastasis
•Amnestic informations or records on schaemic heart disease, claudicatio, universel arteriosklerosis
•Amnestic informations on familar and/or previous tromboembolic event
•Renal failure defined as clinical relevant abnomal levels of creatinine
•Liver failure defined as clinical relevant abnomal levels of ALAT
•Hypersensibility to Voluven, Haemocomplettan eller ingredient substances
•Fertile women not using contraception (contraceptive pill, diaphragm, condom)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method