NCT00255957

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 19, 2006

Status Verified

November 1, 2005

First QC Date

November 16, 2005

Last Update Submit

April 17, 2006

Conditions

Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms

Keywords

Stroke, HES, Coagulation, Kinetics, Hemorehology

Outcome Measures

Primary Outcomes (1)

  • Patients discharged from hospital

Secondary Outcomes (1)

  • Coagulation, rehology and kinetics measurements.

Interventions

HES administrationDRUG
Hydroxy Ethyl Starch administration to stroke patientsDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Cerebral CT at enrolment showing intracranial hemorrhage of any degree-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHypereosinophilic SyndromeThrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and Thrombosis

Study Officials

  • Ramachandran Gopinath, MD,DA,FFARCSI

    NIZAM'S INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

October 1, 2005

Study Completion

March 1, 2006

Last Updated

April 19, 2006

Record last verified: 2005-11