MedTrace Logo

Dilutional Coagulopathy in Patients Undergoing Elective Surgery

NCT00493272 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-12-02

No results posted yet for this study

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.

Conditions

  • Blood Coagulation Disorder

Interventions

DRUG

Fibrinogen

Fibrinogen behandling

Sponsors & Collaborators

  • Christian Fenger-Eriksen

    lead OTHER

Principal Investigators

  • Else Tønnesen, MD, Prof · Aarhus University Hospital, Department of Anaesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Denmark

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493272 on ClinicalTrials.gov