NCT04450446

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

5.7 years

First QC Date

June 24, 2020

Last Update Submit

June 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2015-2020

Study Arms (3)

cerebral hemorrhage

Drug: Low molecular weight heparin

thromboembolism

Drug: Low molecular weight heparin

no thromboembolism and cerebral hemorrhage

Drug: Low molecular weight heparin

Interventions

Anticoagulation therapy

cerebral hemorrhageno thromboembolism and cerebral hemorrhagethromboembolism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • patients with spontaneous cerebral hemorrhage and mechanical valves

You may not qualify if:

  • age\<18y
  • pregnant patients
  • death in 24 hours without anticoagulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

RECRUITING

Second Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • libin li, MD

    second affiliated hospital,school of medicine, zhejiang university,china

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

January 1, 2015

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations