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Bleeding Risk in CVCs

This study has been completed.
Information provided by:
Heidelberg University Identifier:
First received: March 14, 2007
Last updated: January 25, 2013
Last verified: September 2007
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.

Condition Intervention
Bleeding Procedure: central venous catheter application

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Bleeding within 24 hours after cvc application
  • other complications within the first 24 hours

Secondary Outcome Measures:
  • mortality
  • long-term complications

Estimated Enrollment: 200
Study Start Date: November 2005
Study Completion Date: March 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients acquiring a central venous catheter

Exclusion Criteria:

  • Patients pre or post surgery
  • Patients with bleeding due to other reason
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Please refer to this study by its identifier: NCT00448188

University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Kilian Weigand, Dr. University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
Study Director: Jens Encke, Prof. Dr. University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00448188     History of Changes
Other Study ID Numbers: Bleeding risk in CVCs
Study First Received: March 14, 2007
Last Updated: January 25, 2013

Keywords provided by Heidelberg University:
central venous catheter
international normalized ratio
bleeding risk
all patients in need of central venous line
comparison of patients with normal hemostasis to such with disorders in hemostasis

Additional relevant MeSH terms:
Pathologic Processes processed this record on August 21, 2017