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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Cerebral Ischemia; Heparin Causing Adverse Effects in Therapeutic Use; Heparin-induced Thrombosis

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 Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• China
  • Hebei
    • Cangzhou, Hebei, China, 061001
      • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
UFH,once a day
heparin Calcium,every 12 hours
dextran,Salviae,once a day
UFH,continuous intravenous infusion,

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
• Collaborators: Agency for Science, Technology and Research
• Investigators: Principal Investigator: wang zh yong, professor, cangzhou hospital

Publications and helpful links

Helpful Links

• cangzhou hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 27, 2019
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Stroke; Brain Infarction; Infarction; Brain Ischemia; Ischemia; Thrombosis; Cerebral Infarction
• Other Study ID Numbers: 2010CZTCWM