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

Study Overview
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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%.

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

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

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UFH,once a day<br> | |
| heparin Calcium,every 12 hours<br> | |
| dextran,Salviae,once a day<br> | |
| UFH,continuous intravenous infusion,<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of patients with Adverse Events | The adverse complication occurrence rates of the four groups have no significantly different | 4 weeks |