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

Acute Cerebral Ischemia Clinical Trial

— UHPCI  

Official title:

Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378000
• Other study ID #: 2010CZTCWM
• Status: Completed
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine	Cangzhou	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine	Agency for Science, Technology and Research

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of NIHSS at 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	the recurrence rate at 6 months	the ultra-slow continuous intravenous infusion of UFH can significantly decrease the recurrence rate of patients with progressive cerebral infarction,	6 months
Secondary	changs of ADL after 6 months	the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction	6 months
Secondary	Number of patients with Adverse Events	The adverse complication occurrence rates of the four groups have no significantly different	4 weeks

External Links

•   cangzhou hospital