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Influence of Hydroxyehtyl Starch (HES) on Hemorehology, Coagulation and Elimination Kinetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255957
First Posted: November 21, 2005
Last Update Posted: April 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nizam's Institute of Medical Sciences University, India
  Purpose
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.

Condition Intervention
Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms Drug: HES administration Drug: Hydroxy Ethyl Starch administration to stroke patients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Trial to Study the Effects of HES on Coagulation, Hemorehology and Kinetics Comparing Two Different Products.

Further study details as provided by Nizam's Institute of Medical Sciences University, India:

Primary Outcome Measures:
  • Patients discharged from hospital

Secondary Outcome Measures:
  • Coagulation, rehology and kinetics measurements.

Estimated Enrollment: 20
Study Start Date: October 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age 18 - 70 yrs Clinical diagnosis of ischemic stroke No marked spontaneous improvement of symptoms before randomization Written informed consent from nearest relative.

Exclusion Criteria:

Pregnancy Allergy to HES Severe impairment of consciousness Previous stroke with persistent ipsilateral deficits. Seizure at stroke onset. Intracranial neoplasm or AV malformation. Cardiac insufficiency or pulmonary edema Myocardial infarction during the previous 3 months or unstable angina. Severe dehydration Coagulation disorders. Uncontrolled Hypertension. Laboratory findings reflecting severe anemia, renal insufficiency, thrombocytopenia or hepatic insufficiency.

Participation in another clinical trial within the previous 2 months or concurrent treatment with any other experimental drug.

SECONDARY EXCLUSION CRITERIA.

Cerebral CT at enrolment showing intracranial hemorrhage of any degree-

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255957


Sponsors and Collaborators
Nizam's Institute of Medical Sciences University, India
Investigators
Principal Investigator: Ramachandran Gopinath, MD,DA,FFARCSI NIZAM'S INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD, INDIA
  More Information

ClinicalTrials.gov Identifier: NCT00255957     History of Changes
Other Study ID Numbers: NIMS HES 1
First Submitted: November 16, 2005
First Posted: November 21, 2005
Last Update Posted: April 19, 2006
Last Verified: November 2005

Keywords provided by Nizam's Institute of Medical Sciences University, India:
Stroke, HES, Coagulation, Kinetics, Hemorehology