Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction (UHPCI)
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Purpose
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.
| Condition |
|---|
|
Heparin Causing Adverse Effects in Therapeutic Use Heparin-induced Thrombosis Acute Cerebral Ischemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study |
- change of NIHSS at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction,
- the recurrence rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction
- Number of patients with Adverse Events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]The adverse complication occurrence rates of the four groups have no significantly different
Biospecimen Retention: Samples With DNA
serum
| Enrollment: | 480 |
| Study Start Date: | October 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| UFH,once a day |
| heparin Calcium,every 12 hours |
| dextran,Salviae,once a day |
| UFH,continuous intravenous infusion, |
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%.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
From May 2003 to October 2009 480 patients of acute progressive cerebral infraction that matched the standards above were included in the research.
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
Contacts and Locations| China, Hebei | |
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | |
| Cangzhou, Hebei, China, 061001 | |
| Principal Investigator: | wang zh yong, professor | cangzhou hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | wang zhi-yong, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine |
| ClinicalTrials.gov Identifier: | NCT01378000 History of Changes |
| Other Study ID Numbers: | 2010CZTCWM |
| Study First Received: | June 16, 2011 |
| Last Updated: | June 20, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Ischemia Infarction Ischemia Thrombosis Brain Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Necrosis Embolism and Thrombosis Calcium heparin Heparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013