Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heparin Causing Adverse Effects in Therapeutic Use
- Sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- change of NIHSS at 4 weeks
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
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%.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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,
Secondary Outcomes
- the recurrence rate at 6 months(6 months)
- changs of ADL after 6 months(6 months)
- Number of patients with Adverse Events(4 weeks)