Heparin Causing Adverse Effects in Therapeutic UseUHPCINCT01378000
Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction
An observational study of Heparin Causing Adverse Effects in Therapeutic Use and Heparin-induced Thrombosis, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Heparin Causing Adverse Effects in Therapeutic Use, Heparin-induced Thrombosis, Acute Cerebral Ischemia
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, 061001
About this study
Official title: Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
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.
Read the 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%.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UFH,once a day | Not described | |
| heparin Calcium,every 12 hours | Not described | |
| dextran,Salviae,once a day | Not described | |
| UFH,continuous intravenous infusion, | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 4 weeks
Secondary outcomes (3)
the recurrence rate at 6 months
the ultra-slow continuous intravenous infusion of UFH can significantly decrease the recurrence rate of patients with progressive cerebral infarction,
Measured: 6 months
changs of ADL after 6 months
the ultra-slow continuous intravenous infusion of UFH can significantly improve ADL of patients with progressive cerebral infarction
Measured: 6 months
Number of patients with Adverse Events
The adverse complication occurrence rates of the four groups have no significantly different
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Sponsor
- Investigators
- wang zh yong, professor, Principal investigator, cangzhou hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378000
- Sponsor's protocol ID
- 2010CZTCWM
- Acronym
- UHPCI
- Status last verified
- Sep 2010
- First submitted
- 16 Jun 2011
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
- ClinicalTrials.gov ID
- NCT01378000
- Acronym / sponsor ID
- UHPCI / 2010CZTCWM
- Conditions
- Heparin Causing Adverse Effects in Therapeutic Use, Heparin-induced Thrombosis, Acute Cerebral Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UFH,once a day | – | – |
| heparin Calcium,every 12 hours | – | – |
| dextran,Salviae,once a day | – | – |
| UFH,continuous intravenous infusion, | – | – |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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,
3 secondary outcomes
the recurrence rate at 6 months
Time frame: 6 months
changs of ADL after 6 months
Time frame: 6 months
Number of patients with Adverse Events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- cangzhou hospitalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wang zh yong, professor principal investigator
cangzhou hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin Causing Adverse Effects in Therapeutic Use and Heparin-induced Thrombosis, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of NIHSS at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.