Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01378000
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Agency for Science, Technology and Research
Information provided by (Responsible Party):
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Tracking Information
First Submitted Date June 16, 2011
First Posted Date June 22, 2011
Last Update Posted Date April 30, 2019
Study Start Date October 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2011)
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,
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01378000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 20, 2011)
  • 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,
  • 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
  • Number of patients with Adverse Events [ Time Frame: 4 weeks ]
    The adverse complication occurrence rates of the four groups have no significantly different
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction
Official Title Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum
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.
Condition
  • Heparin Causing Adverse Effects in Therapeutic Use
  • Heparin-induced Thrombosis
  • Acute Cerebral Ischemia
Intervention Not Provided
Study Groups/Cohorts
  • UFH,once a day
  • heparin Calcium,every 12 hours
  • dextran,Salviae,once a day
  • UFH,continuous intravenous infusion,
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2011)
480
Original Actual Enrollment Same as current
Actual Study Completion Date August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01378000
Other Study ID Numbers 2010CZTCWM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Study Sponsor Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Collaborators Agency for Science, Technology and Research
Investigators
Principal Investigator: wang zh yong, professor cangzhou hospital
PRS Account Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Verification Date September 2010