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

Sponsor

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01378000

Collaborator

Agency for Science, Technology and Research (Other)

480

Enrollment

Location

Duration (Months)

48.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heparin Causing Adverse Effects in Therapeutic Use Heparin-induced Thrombosis Acute Cerebral Ischemia

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%.

Study Design

Study Type:

Observational

Actual Enrollment :

480 participants

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
UFH,once a day
heparin Calcium,every 12 hours
dextran,Salviae,once a day
UFH,continuous intravenous infusion,

Outcome Measures

Primary Outcome Measures

change of NIHSS at 4 weeks [4 weeks]
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 [6 months]
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 [6 months]
the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction
Number of patients with Adverse Events [4 weeks]
The adverse complication occurrence rates of the four groups have no significantly different

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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