Cerebral HemorrhageNCT04450446
Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
An observational study of Cerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
The investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage
- What is being tested?
- Low molecular weight heparin
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2015to 31 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college.
Who may be able to join
- patients with spontaneous cerebral hemorrhage and mechanical valves
Who cannot join
- age<18y
- pregnant patients
- death in 24 hours without anticoagulant
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
- Recruiting
Second Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
The investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college. Medical documents and patient data were reviewed, including patient age, gender, type of mechanical heart valve, replacement time, replacement site, underlying disease, anticoagulant drugs at admission, type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay, mortality, etc
- Conditions
- Cerebral Hemorrhage
- Being tested
- Low molecular weight heparin
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
Anticoagulation therapy
| Study group | Role | What they receive |
|---|---|---|
| cerebral hemorrhage | Not described Receives: Drug: Low molecular weight heparin | |
| thromboembolism | Not described Receives: Drug: Low molecular weight heparin | |
| no thromboembolism and cerebral hemorrhage | Not described Receives: Drug: Low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival and death patients after follow-up investigation for 60 months
the patients with spontaneous cerebral hemorrhage and mechanical valves in the second affiliated hospital of Zhejiang university medical college.
Measured: 2015-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Jan 2015
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- libin li, MD, Study director, second affiliated hospital,school of medicine, zhejiang university,china
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450446
- Sponsor's protocol ID
- 2020-315
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
- ClinicalTrials.gov ID
- NCT04450446
- Acronym / sponsor ID
- 2020-315
- Conditions
- Cerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 29 Jun 2020 (actual)
- 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.
The investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college. Medical documents and patient data were reviewed, including patient age, gender, type of mechanical heart valve, replacement time, replacement site, underlying disease, anticoagulant drugs at admission, type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay, mortality, etc
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cerebral hemorrhage | – | Drug: Low molecular weight heparin |
| thromboembolism | – | Drug: Low molecular weight heparin |
| no thromboembolism and cerebral hemorrhage | – | Drug: Low molecular weight heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college.
Key inclusion criteria (1 listed)
- patients with spontaneous cerebral hemorrhage and mechanical valves
Key exclusion criteria (3 listed)
- age<18y
- pregnant patients
- death in 24 hours without anticoagulant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight heparinAnticoagulation therapy | Drug | cerebral hemorrhage, no thromboembolism and cerebral hemorrhage, thromboembolism |
Primary outcome
survival and death patients after follow-up investigation for 60 months
Time frame: 2015-2020
the patients with spontaneous cerebral hemorrhage and mechanical valves in the second affiliated hospital of Zhejiang university medical college.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No
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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.
libin li, MD study director
second affiliated hospital,school of medicine, zhejiang university,china
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rubin luo, MD (+86057187783759, keyanlunli_zheer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival and death patients after follow-up investigation for 60 months (time frame: 2015-2020). 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 29 Jun 2020.