Bleeding Risk in CVCs

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448188
• Other study ID #: Bleeding risk in CVCs
• Status: Completed
• Phase: N/A
• First received: March 14, 2007
• Last updated: January 25, 2013
• Start date: November 2005
• Est. completion date: March 2007

Study information

• Verified date: September 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients acquiring a central venous catheter

Exclusion Criteria:

• Patients pre or post surgery

• Patients with bleeding due to other reason

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Procedure:
• central venous catheter application

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding within 24 hours after cvc application
Primary	other complications within the first 24 hours
Secondary	mortality
Secondary	long-term complications