Dilutional Coagulopathy in Patients Undergoing Elective Surgery

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christian Fenger-Eriksen

Criteria

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