- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450446
Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
June 26, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Second Affiliated Hospital,School of Medicine, Zhejiang University
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Second Affiliated Hospital, School of Medicine, Zhejiang University, China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- patients with spontaneous cerebral hemorrhage and mechanical valves
Exclusion Criteria:
- age<18y
- pregnant patients
- death in 24 hours without anticoagulant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cerebral hemorrhage
|
Anticoagulation therapy
|
|
thromboembolism
|
Anticoagulation therapy
|
|
no thromboembolism and cerebral hemorrhage
|
Anticoagulation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2015-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: libin li, MD, second affiliated hospital,school of medicine, zhejiang university,china
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Anticipated)
August 31, 2020
Study Completion (Anticipated)
August 31, 2020
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 26, 2020
First Posted (Actual)
June 29, 2020
Study Record Updates
Last Update Posted (Actual)
June 29, 2020
Last Update Submitted That Met QC Criteria
June 26, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Cerebral Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- 2020-315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.