Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 10:36 PM
Study NCT ID:
NCT01462968
Status:
WITHDRAWN
Last Update Posted:
2015-06-26
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
Official Title:
Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
Status:
WITHDRAWN
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study never started due to problems with Laboratory facilities in collaborating center
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find the heparinization method, which
1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.
The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.
1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.
The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: