Clinical trial NCT01378000: Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction
Official title: Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heparin Causing Adverse Effects in Therapeutic Use
Heparin-induced Thrombosis
Acute Cerebral Ischemia
Lead sponsor: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
First posted: 2011-06-22
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From May 2003 to October 2009 480 patients of acute progressive cerebral infraction that matched the standards above were included in the research.

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%.

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
* Pregnant

Primary outcomes:
measure: change of NIHSS at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: the recurrence rate at 6 months
timeFrame: 6 months
measure: changs of ADL after 6 months
timeFrame: 6 months
measure: Number of patients with Adverse Events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
state: Hebei
Study officials:
affiliation: cangzhou hospital
name: wang zh yong, professor
role: PRINCIPAL_INVESTIGATOR
References: