Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448188
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2007-03-14
Brief Title:
Bleeding Risk in CVCs
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15 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 15 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None