Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction

NCT ID: NCT01378000

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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%.

Conditions

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Heparin Causing Adverse Effects in Therapeutic Use Heparin-induced Thrombosis Acute Cerebral Ischemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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UFH,once a day

No interventions assigned to this group

heparin Calcium,every 12 hours

No interventions assigned to this group

dextran,Salviae,once a day

No interventions assigned to this group

UFH,continuous intravenous infusion,

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Science, Technology and Research

OTHER

Sponsor Role collaborator

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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wang zh yong, professor

Role: PRINCIPAL_INVESTIGATOR

cangzhou hospital

Locations

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Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, China

Site Status

Countries

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China

Related Links

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http://www.cz96130.com

cangzhou hospital

Other Identifiers

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2010CZTCWM

Identifier Type: -

Identifier Source: org_study_id

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