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NCT Number: NCT01378000

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

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.

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Key information

Conditions

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

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, 061001, China

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change of NIHSS at 4 weeks

    Time frame: 4 weeks

    the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction,

Secondary outcomes

  1. the recurrence rate at 6 months

    Time frame: 6 months

    the ultra-slow continuous intravenous infusion of UFH can significantly decrease the recurrence rate of patients with progressive cerebral infarction,

  2. changs of ADL after 6 months

    Time frame: 6 months

    the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction

  3. Number of patients with Adverse Events

    Time frame: 4 weeks

    The adverse complication occurrence rates of the four groups have no significantly different

Sponsors and collaborators

Lead sponsor

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Other

Collaborators

  • Agency for Science, Technology and Research

Registry information

Official study title

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

Acronym: UHPCI

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2011
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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