NCT00448188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
Last Updated

January 28, 2013

Status Verified

September 1, 2007

First QC Date

March 14, 2007

Last Update Submit

January 25, 2013

Conditions

Bleeding

Keywords

central venous catheterinternational normalized ratiothrombocytesbleeding riskall patients in need of central venous linecomparison of patients with normal hemostasis to such with disorders in hemostasis

Outcome Measures

Primary Outcomes (2)

  • Bleeding within 24 hours after cvc application

  • other complications within the first 24 hours

Secondary Outcomes (2)

  • mortality

  • long-term complications

Interventions

central venous catheter applicationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients acquiring a central venous catheter

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19444412DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kilian Weigand, Dr.

    University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany

    PRINCIPAL INVESTIGATOR

  • Jens Encke, Prof. Dr.

    University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 16, 2007

Study Start

November 1, 2005

Study Completion

March 1, 2007

Last Updated

January 28, 2013

Record last verified: 2007-09

Locations

DE(1)