Bleeding Risk in CVCs - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

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
Estimated 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

Contacts


Contact: Kilian Weigand, Dr.	6221-5638747 ext +49	kilian.weigand@med.uni-heidelberg.de

Contact: Jens Encke, Prof. Dr.	6221-568825 ext +49	jens.encke@med.uni-heidelberg.de

Locations


Germany
	University Hospital Heidelberg	Recruiting
	Heidelberg, Germany, 69120
	Contact: Kilian Weigand, Dr. 6221-5638747 ext +49 kilian.weigand@med.uni-heidelberg.de
	Contact: Jens Encke, Prof. Dr. 6221-568825 ext +49 jens.encke@med.uni-heidelberg.de
	Principal Investigator: Kilian Weigand, Dr.
	Sub-Investigator: Alexandra Zahn, Dr.

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

Study ID Numbers:	Bleeding risk in CVCs
First Received:	March 14, 2007
Last Updated:	March 15, 2007
ClinicalTrials.gov Identifier:	NCT00448188
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

Study placed in the following topic categories:

Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00448188