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Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2

NCT ID: NCT03306836

Last Updated: 2017-10-11

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

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-08-31

Brief Summary

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In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.

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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Hybrid operation Cerebral Aneurysm Arteriovenous Malformations Anticoagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard dose group of Heparin Sodium

First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.

Group Type EXPERIMENTAL

Heparin Sodium

Intervention Type DRUG

Infused with 5000 IU of Heparin Sodium

Heparin Sodium

Intervention Type DRUG

Infusion Heparin Sodium at a rate of 18 IU / kg.h

Low dose group of Heparin Sodium

infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.

Group Type ACTIVE_COMPARATOR

Heparin Sodium

Intervention Type DRUG

Infusion Heparin Sodium at a rate of 18 IU / kg.h

Interventions

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Heparin Sodium

Infused with 5000 IU of Heparin Sodium

Intervention Type DRUG

Heparin Sodium

Infusion Heparin Sodium at a rate of 18 IU / kg.h

Intervention Type DRUG

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

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role collaborator

Kunming Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Nanjing PLA General Hospital

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

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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2016YFC1301800-2

Identifier Type: -

Identifier Source: org_study_id