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Bleeding Risk in CVCs

This study has been completed.
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00448188
First received: March 14, 2007
Last updated: January 25, 2013
Last verified: September 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters

Further study details as provided by University of Heidelberg:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients acquiring a central venous catheter

Exclusion Criteria:

  • Patients pre or post surgery
  • Patients with bleeding due to other reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448188

Locations
Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University of Heidelberg
Investigators
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

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00448188     History of Changes
Other Study ID Numbers: Bleeding risk in CVCs
Study First Received: March 14, 2007
Last Updated: January 25, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
central venous catheter
international normalized ratio
thrombocytes
 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:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013