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

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Brief Title

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

Official Title

Multi-center, Single-blind, Prospective Cohort Study of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation

Brief Summary

      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

      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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery

Secondary Outcome

 Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery

Condition

Cerebral Aneurysm


Study Arms / Comparison Groups

 aneurysm
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

556

Start Date

September 2016

Completion Date

August 2021

Primary Completion Date

September 2020

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 010-67096510, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03306823

Organization ID

2016YFC1301800-Anticoagulation


Responsible Party

Principal Investigator

Study Sponsor

Beijing Tiantan Hospital

Collaborators

 Tang-Du Hospital

Study Sponsor

, , 


Verification Date

October 2017