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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01378000
Acronym
UHPCI
Enrollment
480
Registered
2011-06-22
Start date
2009-10-31
Completion date
2010-08-31
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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%.

Interventions

None listed

Sponsors

Agency for Science, Technology and Research
CollaboratorOTHER
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of NIHSS at 4 weeks4 weeksthe ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction,

Secondary

MeasureTime frameDescription
the recurrence rate at 6 months6 monthsthe ultra-slow continuous intravenous infusion of UFH can significantly decrease the recurrence rate of patients with progressive cerebral infarction,
changs of ADL after 6 months6 monthsthe ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction
Number of patients with Adverse Events4 weeksThe adverse complication occurrence rates of the four groups have no significantly different

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026