Bleeding Risk in CVCs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00448188
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : January 28, 2013
Information provided by:
Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Bleeding Procedure: central venous catheter application Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : November 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Primary Outcome Measures :
  1. Bleeding within 24 hours after cvc application
  2. other complications within the first 24 hours

Secondary Outcome Measures :
  1. mortality
  2. long-term complications

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00448188     History of Changes
Other Study ID Numbers: Bleeding risk in CVCs
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: September 2007

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