Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04450446
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 68
• Patients Per Site: 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Hemorrhage	Drug: Low molecular weight heparin

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Aug 31, 2020
• Anticipated Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
cerebral hemorrhage	Drug: Low molecular weight heparin; Anticoagulation therapy
thromboembolism	Drug: Low molecular weight heparin; Anticoagulation therapy
no thromboembolism and cerebral hemorrhage	Drug: Low molecular weight heparin; Anticoagulation therapy

Outcome Measures

Primary Outcome Measures

1. survival and death patients after follow-up investigation for 60 months [2015-2020]

   the patients with spontaneous cerebral hemorrhage and mechanical valves in the second affiliated hospital of Zhejiang university medical college.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with spontaneous cerebral hemorrhage and mechanical valves

Exclusion Criteria:

• age<18y

• pregnant patients

• death in 24 hours without anticoagulant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang	China	310000
2	Second Affiliated Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Director: libin li, MD, second affiliated hospital,school of medicine, zhejiang university,china

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04450446
• Other Study ID Numbers: 2020-315
• First Posted: Jun 29, 2020
• Last Update Posted: Jun 29, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hemorrhage; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin

Study Results

No Results Posted as of Jun 29, 2020