Stroke Patients Presenting Within 24 Hrs of Onset of SymptomsNCT00255957
Influence of Hydroxyehtyl Starch (HES) on Hemorehology, Coagulation and Elimination Kinetics
A study testing HES administration and Hydroxy Ethyl Starch administration to stroke patients in people with Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms, run by Nizam's Institute of Medical Sciences University, India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms
- What is being tested?
- HES administration and Hydroxy Ethyl Starch administration to stroke patients
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 yrs Clinical diagnosis of ischemic stroke No marked spontaneous improvement of symptoms before randomization Written informed consent from nearest relative.
- -
Who cannot join
- 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-
About this study
Official title: Clinical Trial to Study the Effects of HES on Coagulation, Hemorehology and Kinetics Comparing Two Different Products.
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.
Read the 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.
- Being tested
- HES administration, Hydroxy Ethyl Starch administration to stroke patients
- Keywords
- Stroke, HES, Coagulation, Kinetics, Hemorehology
- Medical subject headings
- Stroke, Hypereosinophilic Syndrome, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES administrationDrug
Hydroxy Ethyl Starch administration to stroke patientsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients discharged from hospital
Secondary outcomes (1)
Coagulation, rehology and kinetics measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startOct 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Patients Presenting Within 24 Hrs of Onset of SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Nizam's Institute of Medical Sciences University, India
- Sponsor type
- University, hospital or other
- Investigators
- Ramachandran Gopinath, MD,DA,FFARCSI, Principal investigator, NIZAM'S INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255957
- Sponsor's protocol ID
- NIMS HES 1
- Status last verified
- Nov 2005
- First submitted
- 16 Nov 2005
- Last updated
- 19 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Study the Effects of HES on Coagulation, Hemorehology and Kinetics Comparing Two Different Products.
- ClinicalTrials.gov ID
- NCT00255957
- Acronym / sponsor ID
- NIMS HES 1
- Keywords
- Stroke, HES, Coagulation, Kinetics, Hemorehology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Nizam's Institute of Medical Sciences University, IndiaUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Mar 2006
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 70 yrs Clinical diagnosis of ischemic stroke No marked spontaneous improvement of symptoms before randomization Written informed consent from nearest relative.
- -
Key exclusion criteria (4 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HES administration | Drug | – |
| Hydroxy Ethyl Starch administration to stroke patients | Drug | – |
Primary outcome
Patients discharged from hospital
1 secondary outcome
Coagulation, rehology and kinetics measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramachandran Gopinath, MD,DA,FFARCSI principal investigator
NIZAM'S INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD, INDIA
Questions about this trial
What is this clinical trial studying?
A study testing HES administration and Hydroxy Ethyl Starch administration to stroke patients in people with Stroke Patients Presenting Within 24 Hrs of Onset of Symptoms, run by Nizam's Institute of Medical Sciences University, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients discharged from hospital. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2006.