Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
Study NCT ID:
NCT00255957
Status:
COMPLETED
Last Update Posted:
2006-04-19
First Post:
2005-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Hydroxyehtyl Starch (HES) on Hemorehology, Coagulation and Elimination Kinetics
Sponsor:
Nizam's Institute of Medical Sciences University, India
Organization:
Study Overview
Official Title:
Clinical Trial to Study the Effects of HES on Coagulation, Hemorehology and Kinetics Comparing Two Different Products.
Status:
COMPLETED
Status Verified Date:
2005-11
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 use of HES has been found clinically to improve patients with stroke if administered within a window period by means of hemodilution to improve rehology. We propose to see the effects of long term administraion of HES in the amounts required for treating stroke patients and study the effects on the kinetics of HES, its effects on coagulation and hemorheology.
Detailed Description:
Patients with stroke benefit with hemodilution when administered HES in a window period and continued for a period of 10 days. Hemodilution improves the hemorheology and thus possibly preserves the cerebral tissues in the penumbra regions of affected vessels.
We propose to see the effects of prolonged administration of HES from different makes and study the kinetics, hemorehology and coagulation parameters by TEG as there is no literature on kinetics and coagulation follwing prolonged use in stroke patients and also study their neurological outcomes.
Patients presenting to the Emergency department or outpatient department within 24 hrs of manifestation of symptoms will be recruited to the study after taking informed consent in a language the patients/ family understand by the study personnel identified and authorized to do the same.
The patients will then be randomly allocated to receive HES of either make for 10 day with 10 patients in each group.
The randomization is by random number generation by computer.
The product is blinded to the patient and observer by black cover with only the label A OR B of each group.
Blood Samples will be drawn at time of randomization, after 3, 5 and 10 days for rehological, coagulation effects and kinetics of HES, stored as per requirements and analyzed. Routine biochemical tests as prescribed by the physician will be undertaken as required.
Satistical analysis of data will be done by SPSS.
We propose to see the effects of prolonged administration of HES from different makes and study the kinetics, hemorehology and coagulation parameters by TEG as there is no literature on kinetics and coagulation follwing prolonged use in stroke patients and also study their neurological outcomes.
Patients presenting to the Emergency department or outpatient department within 24 hrs of manifestation of symptoms will be recruited to the study after taking informed consent in a language the patients/ family understand by the study personnel identified and authorized to do the same.
The patients will then be randomly allocated to receive HES of either make for 10 day with 10 patients in each group.
The randomization is by random number generation by computer.
The product is blinded to the patient and observer by black cover with only the label A OR B of each group.
Blood Samples will be drawn at time of randomization, after 3, 5 and 10 days for rehological, coagulation effects and kinetics of HES, stored as per requirements and analyzed. Routine biochemical tests as prescribed by the physician will be undertaken as required.
Satistical analysis of data will be done by SPSS.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: