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OpenTrials
Completed

NCT Number: NCT00448188

Bleeding Risk in CVCs

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.

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients acquiring a central venous catheter

Exclusion criteria

  • Patients pre or post surgery
  • Patients with bleeding due to other reason

Treatment and study plan

central venous catheter application

Procedure

Primary outcomes

  1. Bleeding within 24 hours after cvc application

  2. other complications within the first 24 hours

Secondary outcomes

  1. mortality

  2. long-term complications

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Mar 16, 2007
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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