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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D017681', 'term': 'Hypereosinophilic Syndrome'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2006-04-17', 'studyFirstSubmitDate': '2005-11-16', 'studyFirstSubmitQcDate': '2005-11-16', 'lastUpdatePostDateStruct': {'date': '2006-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients discharged from hospital'}], 'secondaryOutcomes': [{'measure': 'Coagulation, rehology and kinetics measurements.'}]}, 'conditionsModule': {'keywords': ['Stroke, HES, Coagulation, Kinetics, Hemorehology'], 'conditions': ['Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWe 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.\n\nPatients 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.\n\nThe patients will then be randomly allocated to receive HES of either make for 10 day with 10 patients in each group.\n\nThe randomization is by random number generation by computer.\n\nThe product is blinded to the patient and observer by black cover with only the label A OR B of each group.\n\nBlood 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.\n\nSatistical analysis of data will be done by SPSS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 - 70 yrs Clinical diagnosis of ischemic stroke No marked spontaneous improvement of symptoms before randomization Written informed consent from nearest relative.\n\n\\-\n\nExclusion Criteria:\n\nPregnancy 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.\n\nParticipation in another clinical trial within the previous 2 months or concurrent treatment with any other experimental drug.\n\nSECONDARY EXCLUSION CRITERIA.\n\nCerebral CT at enrolment showing intracranial hemorrhage of any degree-'}, 'identificationModule': {'nctId': 'NCT00255957', 'briefTitle': 'Influence of Hydroxyehtyl Starch (HES) on Hemorehology, Coagulation and Elimination Kinetics', 'organization': {'class': 'OTHER', 'fullName': "Nizam's Institute of Medical Sciences University, India"}, 'officialTitle': 'Clinical Trial to Study the Effects of HES on Coagulation, Hemorehology and Kinetics Comparing Two Different Products.', 'orgStudyIdInfo': {'id': 'NIMS HES 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HES administration', 'type': 'DRUG'}, {'name': 'Hydroxy Ethyl Starch administration to stroke patients', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ramachandran Gopinath, MD,DA,FFARCSI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "NIZAM'S INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD, INDIA"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nizam's Institute of Medical Sciences University, India", 'class': 'OTHER'}}}}