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Bleeding Risk in CVCs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00448188
Enrollment
200
Registered
2007-03-16
Start date
2005-11-30
Completion date
2007-03-31
Last updated
2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREcentral venous catheter application

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients acquiring a central venous catheter

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Bleeding within 24 hours after cvc application
other complications within the first 24 hours

Secondary

MeasureTime frame
mortality
long-term complications

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026