Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493272
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2007-06-27
Brief Title:
Dilutional Coagulopathy in Patients Undergoing Elective Surgery
Sponsor:
Christian Fenger-Eriksen
Organization:
University of Aarhus
Study Overview
Official Title:
Fibrinogen vs Placebo for Improvement of Clot Strength
Status:
COMPLETED
Status Verified Date:
2015-11
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:
The purpose of the present study is to perform a comprehensive description of haemostasis parameters before and after haemodilution with Hydroxyethyl starch HES following acute bleeding during elective surgery Moreover the study aims to test the in vivo haemostatic potential of fibrinogen concentrate in dilutional coagulopathy caused by HES in a clinical prospective placebo-controlled randomised setup
We hypothesise a A coagulopathy is induced following in vivo haemodilution b the coagulopathy is improved or partially improved by fibrinogen
We hypothesise a A coagulopathy is induced following in vivo haemodilution b the coagulopathy is improved or partially improved by fibrinogen
Detailed Description:
Background Hydroxyethyl starch HES is a group of artificial colloid solutions widely used for plasma expansion and volume resuscitation HES consist of branched chains of hydroxylated glucose molecules defined by average molecular weight degree of hydroxyethylation and C2C6 ratio Several clinical reports and in vitro experiments have documented an impaired coagulation system induced by haemodilution with HES and other colloid plasma expanders The exact mechanisms responsible for HES induced coagulopahty are not fully understood although reduced levels of von Willebrand factor vWF acquired platelet dysfunction reduced factor VIII levels and dysfunctional fibrinogen polymerization seems to reflect an important aspect of the pathogenesis
Experimental laboratory studies performed in our centre and verified by several other research groups have shown successful reversal of the colloid plasma expander induced coagulopathy by fibrinogen concentrate10-13 So far the present knowledge are based on laboratory experiments and animal studies Hence it appears desirable to perform a comprehensive description of haemostasis parameters following HES induced dilutional coagulopathy in an acute clinical bleeding situation
Materials and Methods
Study design Clinical prospective double-blind randomised place-controlled trial Blood samples
Primary end point
Dynamic whole blood clot formation
Secondary end points
A Single coagulation factor activities B Platelet function C Whole blood clot stability D Thrombin generation
Perspectives
Serious surgical and traumatic bleedings are common and associated with a high mortality rate The present study can significantly contribute to our overall understanding of the mechanisms involved in HES induced dilutional coagulopathy
Experimental laboratory studies performed in our centre and verified by several other research groups have shown successful reversal of the colloid plasma expander induced coagulopathy by fibrinogen concentrate10-13 So far the present knowledge are based on laboratory experiments and animal studies Hence it appears desirable to perform a comprehensive description of haemostasis parameters following HES induced dilutional coagulopathy in an acute clinical bleeding situation
Materials and Methods
Study design Clinical prospective double-blind randomised place-controlled trial Blood samples
Primary end point
Dynamic whole blood clot formation
Secondary end points
A Single coagulation factor activities B Platelet function C Whole blood clot stability D Thrombin generation
Perspectives
Serious surgical and traumatic bleedings are common and associated with a high mortality rate The present study can significantly contribute to our overall understanding of the mechanisms involved in HES induced dilutional coagulopathy
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