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

Completed

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

• Registration Number: NCT01378000
• Lead Sponsor: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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%.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Last Update Submitted: 2019-04-27
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Cangzhou, Hebei, China