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

June 16, 2011
June 20, 2011
October 2009
August 2010   (final data collection date for primary outcome measure)
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,
Same as current
Complete list of historical versions of study NCT01378000 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction
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.

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%.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum

Probability Sample

From May 2003 to October 2009 480 patients of acute progressive cerebral infraction that matched the standards above were included in the research.

  • Heparin Causing Adverse Effects in Therapeutic Use
  • Heparin-induced Thrombosis
  • Acute Cerebral Ischemia
Not Provided
  • UFH,once a day
  • heparin Calcium,every 12 hours
  • dextran,Salviae,once a day
  • UFH,continuous intravenous infusion,
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01378000
2010CZTCWM
Yes
wang zhi-yong, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Agency for Science, Technology and Research
Principal Investigator: wang zh yong, professor cangzhou hospital
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP