Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

556 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-08-31

Brief Summary

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In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.

Detailed Description

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This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. This study is a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative activated coagulation time Changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. On the stage of randomized controlled study. This study is a multicenter, single-blind, prospective, randomized controlled study. Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.

Conditions

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Cerebral Aneurysm Arteriovenous Malformations

Keywords

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Cerebral Aneurysm Arteriovenous Malformations Hybrid operation Anticoagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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aneurysm

For cerebral aneurysm with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.

No interventions assigned to this group

arteriovenous malformations

For arteriovenous malformations with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1.All patients undergoing hybird surgery.

Exclusion Criteria

1. Poor general condition , severe primary disease, surgical contraindications
2. Patient or family refused surgery
3. Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
4. Combined with other hemorrhagic cerebrovascular disease
5. Combined with malignant brain tumor
6. Perinatal, Pregnancy
7. Patients unwilling to participate in the trial

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Yong Cao

Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Cao, Doctor

Role: CONTACT

Phone: 010-67096510

Email: [email protected]

Facility Contacts

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Yong Cao, M.D.

Role: primary

Other Identifiers

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2016YFC1301800-Anticoagulation

Identifier Type: -

Identifier Source: org_study_id