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

This study has been completed.
Sponsor:
Collaborator:
Agency for Science, Technology and Research
Information provided by:
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
ClinicalTrials.gov Identifier:
NCT01378000
First received: June 16, 2011
Last updated: June 20, 2011
Last verified: September 2010
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study

Resource links provided by NLM:


Further study details as provided by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine:

Primary Outcome Measures:
  • change of NIHSS at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction,


Secondary Outcome Measures:
  • the recurrence rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    the ultra-slow continuous intravenous infusion of UFH can significantly decrease the recurrence rate of patients with progressive cerebral infarction,

  • changs of ADL after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction

  • Number of patients with Adverse Events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    The adverse complication occurrence rates of the four groups have no significantly different


Biospecimen Retention:   Samples With DNA

serum


Enrollment: 480
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
UFH,once a day
heparin Calcium,every 12 hours
dextran,Salviae,once a day
UFH,continuous intravenous infusion,

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%.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01378000

Locations
China, Hebei
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, China, 061001
Sponsors and Collaborators
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Agency for Science, Technology and Research
Investigators
Principal Investigator: wang zh yong, professor cangzhou hospital
  More Information

Additional Information:
No publications provided

Responsible Party: wang zhi-yong, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
ClinicalTrials.gov Identifier: NCT01378000     History of Changes
Other Study ID Numbers: 2010CZTCWM
Study First Received: June 16, 2011
Last Updated: June 20, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Ischemia
Infarction
Ischemia
Thrombosis
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Embolism and Thrombosis
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014