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Clinical Trials/NCT00448188
NCT00448188
Completed
Not Applicable

Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters

Heidelberg University1 site in 1 country200 target enrollmentNovember 2005
ConditionsBleeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bleeding
Sponsor
Heidelberg University
Enrollment
200
Locations
1
Primary Endpoint
Bleeding within 24 hours after cvc application
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR > 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR > 1.5 and platelets < 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
March 2007
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • All patients acquiring a central venous catheter

Exclusion Criteria

  • Patients pre or post surgery
  • Patients with bleeding due to other reason

Outcomes

Primary Outcomes

Bleeding within 24 hours after cvc application

other complications within the first 24 hours

Secondary Outcomes

  • mortality
  • long-term complications

Study Sites (1)

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