Back to resultsBleeding Risk in CVCs
Primary Purpose
Bleeding
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
central venous catheter application
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- All patients acquiring a central venous catheter
Exclusion Criteria:
- Patients pre or post surgery
- Patients with bleeding due to other reason
Sites / Locations
- University Hospital Heidelberg
Outcomes
Primary Outcome Measures
Bleeding within 24 hours after cvc application
other complications within the first 24 hours
Secondary Outcome Measures
mortality
long-term complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00448188
Brief Title
Bleeding Risk in CVCs
Official Title
Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
central venous catheter application
Primary Outcome Measure Information:
Title
Bleeding within 24 hours after cvc application
Title
other complications within the first 24 hours
Secondary Outcome Measure Information:
Title
mortality
Title
long-term complications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients acquiring a central venous catheter
Exclusion Criteria:
Patients pre or post surgery
Patients with bleeding due to other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kilian Weigand, Dr.
Organizational Affiliation
University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Encke, Prof. Dr.
Organizational Affiliation
University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19444412
Citation
Weigand K, Encke J, Meyer FJ, Hinkel UP, Munder M, Stremmel W, Zahn A. Low levels of prothrombin time (INR) and platelets do not increase the risk of significant bleeding when placing central venous catheters. Med Klin (Munich). 2009 May 15;104(5):331-5. doi: 10.1007/s00063-009-1070-2. Epub 2009 May 16.
Results Reference
derived
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Bleeding Risk in CVCs
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