- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378000
Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction (UHPCI)
April 27, 2019 updated by: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
A clinical trial to study the effects of dosage, infusion methods and complications of unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted.
In this study, we observed the effects of four UFH treatments on 480 acute progressive cerebral infraction patients during from the 6th and the 72nd hour after the attack.
It was concluded that the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction, increase the cure rate, decrease the recurrence rate, and improve long-term quality of daily life.
It is more effective than the treatment of intravenous infusion of low- molecular- weight UFH at once a day, and the risk of bleeding may not necessarily be increased.
Study Overview
Status
Completed
Detailed Description
Treatment' effectiveness rates of the four groups were 95.80%, 85.22%, 85.47%, and 87.72% respectively.
The result of Group A was significantly different from those of Group B, C, and D (p <0.05).
The adverse complication occurrence rates of the four groups were 5.88%, 3.48%, 4.27% and 3.51%.
Study Type
Observational
Enrollment (Actual)
480
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Cangzhou, Hebei, China, 061001
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
From May 2003 to October 2009 480 patients of acute progressive cerebral infraction that matched the standards above were included in the research.
Description
Inclusion Criteria:
- Time after breakout: 6- 72 hours
- Blood pressure: below 180/100 mm Hg (1 mm Hg= 0.133 kPa)
- Paralyzed limb muscle strength: Level 0
- Being conscious or in mild or moderate coma, and hernia- free
- The nerve function continued to aggravate from several hours to a week after the breakout.
- No abnormal blood coagulation Platelet count Plt >10×109/L
- Brain CT or MRI confirming and ruling out the occurrence of bleeding
- Match the diagnostic standards of acute cerebral infraction established by the 4th Chinese China Neurology Association
- Informed consent Agreement Signed
Exclusion Criteria:
- History of intracranial hemorrhage bleeding risk or Plt <10 × 109/ L
- Record of severe heart, liver, or renal insufficiency or severe diabetes mellitus
- Infarct area larger than 1/3 of hemispheric area
- Pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
UFH,once a day
|
heparin Calcium,every 12 hours
|
dextran,Salviae,once a day
|
UFH,continuous intravenous infusion,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of NIHSS at 4 weeks
Time Frame: 4 weeks
|
the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction,
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the recurrence rate at 6 months
Time Frame: 6 months
|
the ultra-slow continuous intravenous infusion of UFH can significantly decrease the recurrence rate of patients with progressive cerebral infarction,
|
6 months
|
changs of ADL after 6 months
Time Frame: 6 months
|
the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction
|
6 months
|
Number of patients with Adverse Events
Time Frame: 4 weeks
|
The adverse complication occurrence rates of the four groups have no significantly different
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: wang zh yong, professor, cangzhou hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
June 16, 2011
First Submitted That Met QC Criteria
June 20, 2011
First Posted (Estimate)
June 22, 2011
Study Record Updates
Last Update Posted (Actual)
April 30, 2019
Last Update Submitted That Met QC Criteria
April 27, 2019
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010CZTCWM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Cerebral Ischemia
-
Assistance Publique - Hôpitaux de ParisCompletedAcute Stroke | Acute Cerebral IschemiaFrance
-
NoNO Inc.University of British Columbia; University of Toronto; University of Calgary; Genome... and other collaboratorsCompletedAcute Cerebral IschemiaCanada
-
Pharmazz, Inc.RecruitingAcute Cerebral IschemiaIndia
-
Inje University Haeundae Paik HospitalKorean Neuroendovascular SocietyEnrolling by invitationAcute Cerebral Ischemia Requiring for Mechanical ThrombectomyKorea, Republic of
-
Nanfang Hospital, Southern Medical UniversityRecruitingIschemia-reperfusion Injury | Cerebral Edema | Ischemic Stroke, AcuteChina
-
Beijing Tiantan HospitalRecruiting
-
University of California, San FranciscoRecruitingStroke | Ischemic Stroke | Cerebral Infarction | Subarachnoid Hemorrhage | Hemorrhagic Stroke | Acute Stroke | Cerebral Stroke | Cerebral Ischemia | Cerebral Vascular AccidentUnited States
-
Central Hospital, Nancy, FranceRecruiting
-
MIVI Neuroscience, Inc.CompletedAcute Stroke | Cerebral IschemiaFrance, United States
-
Pharmazz, Inc.Completed