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

NCT01378000 | Completed DMC

• 1 other identifier: 2010CZTCWM
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the recurrence rate at 6 months

  6 months

• changs of ADL after 6 months

  6 months

• Number of patients with Adverse Events

  4 weeks

Study Arms (4)

UFH,once a day

heparin Calcium,every 12 hours

dextran,Salviae,once a day

UFH,continuous intravenous infusion,

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine: lead
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, 061001, China

Location

Related Links

• cangzhou hospital

Biospecimen

Retention: SAMPLES WITH DNA

serum

Study Officials

• wang zh yong, professor

  cangzhou hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 22, 2011
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 30, 2019

Record last verified: 2010-09

Locations

CN (1)