Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518544
Status:
UNKNOWN
Last Update Posted:
2007-08-20
First Post:
2007-08-16
Brief Title:
Hemostatic Effect of Various Colloid Solutions
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Hemostatic Effect of Various Colloid Solutions According to Blood Types
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
RECRUITING
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:
Background Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart Infusion of hydroxyethyl starch HES impairs coagulation and in O blood type apparent coagulopathy can develop after HES infusion A newly market-released balanced HES 670075 has physiologic pH and balanced electrolytes including calcium which are beneficial to coagulation Studies comparing balanced HES 670075 with saline-based HES 13004 previously known the least coagulopathic are rare Therefore we try to reveal the difference of coagulation pHelectrolyte balance and bleeding amount between the non-O and O blood types after infusion of these two newest HES
Methods Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled 20 mlkg of saline-based HES 13004 or balanced HES 670075 was administered during operation Blood loss coagulation and metabolic profiles were checked at pre-infusion T0 5 min after infusion T1 4 hrs after infusion T2 and 24 hrs after infusion T4
Methods Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled 20 mlkg of saline-based HES 13004 or balanced HES 670075 was administered during operation Blood loss coagulation and metabolic profiles were checked at pre-infusion T0 5 min after infusion T1 4 hrs after infusion T2 and 24 hrs after infusion T4
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