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Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 (EAPCAAMHO2)

Primary Purpose

Cerebral Aneurysm, Arteriovenous Malformations

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Heparin Sodium
Heparin Sodium
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Aneurysm focused on measuring Hybrid operation, Cerebral Aneurysm, Arteriovenous Malformations, Anticoagulation

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard dose group of Heparin Sodium

Low dose group of Heparin Sodium

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.

Secondary Outcome Measures

Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery
Hemorrhage event include intracranial hemorrhage caused by non-surgical reasons, as well as other organs or parts of the massive bleeding or small bleeding, Including subperitoneal hemorrhage, intraocular hemorrhage, gross hematuria, epistaxis time prolonged or repeated, gastrointestinal bleeding, hemoptysis, subconjunctival hemorrhage, hematoma greater than 5cm, bleeding difficult to control the and so on.
Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery
Ischemia event include Cerebral infarction and transient ischemic attack.
Intraoperative blood loss
All the blood lost during the surgery should be collected and measured.

Full Information

First Posted
May 31, 2017
Last Updated
October 10, 2017
Sponsor
Beijing Tiantan Hospital
Collaborators
Tang-Du Hospital, Kunming Medical University, First Affiliated Hospital of Fujian Medical University, Nanjing PLA General Hospital, Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03306836
Brief Title
Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2
Acronym
EAPCAAMHO2
Official Title
Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Tang-Du Hospital, Kunming Medical University, First Affiliated Hospital of Fujian Medical University, Nanjing PLA General Hospital, Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm, Arteriovenous Malformations
Keywords
Hybrid operation, Cerebral Aneurysm, Arteriovenous Malformations, Anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard dose group of Heparin Sodium
Arm Type
Experimental
Arm Description
First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.
Arm Title
Low dose group of Heparin Sodium
Arm Type
Active Comparator
Arm Description
infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.
Intervention Type
Drug
Intervention Name(s)
Heparin Sodium
Intervention Description
Infused with 5000 IU of Heparin Sodium
Intervention Type
Drug
Intervention Name(s)
Heparin Sodium
Intervention Description
Infusion Heparin Sodium at a rate of 18 IU / kg.h
Primary Outcome Measure Information:
Title
Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
Description
Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.
Time Frame
From the beginning of surgery to 48 hours after surgery
Secondary Outcome Measure Information:
Title
Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery
Description
Hemorrhage event include intracranial hemorrhage caused by non-surgical reasons, as well as other organs or parts of the massive bleeding or small bleeding, Including subperitoneal hemorrhage, intraocular hemorrhage, gross hematuria, epistaxis time prolonged or repeated, gastrointestinal bleeding, hemoptysis, subconjunctival hemorrhage, hematoma greater than 5cm, bleeding difficult to control the and so on.
Time Frame
From the beginning of surgery to 48 hours after surgery
Title
Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery
Description
Ischemia event include Cerebral infarction and transient ischemic attack.
Time Frame
From the beginning of surgery to 48 hours after surgery
Title
Intraoperative blood loss
Description
All the blood lost during the surgery should be collected and measured.
Time Frame
From the beginning of surgery to 48 hours after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.All patients undergoing hybird surgery. Exclusion Criteria: Poor general condition , severe primary disease, surgical contraindications Patient or family refused surgery Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms Combined with other hemorrhagic cerebrovascular disease Combined with malignant brain tumor Perinatal, Pregnancy Patients unwilling to participate in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, Doctor
Phone
010-67096510
Email
caoyong6@hotmail.com
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.
Phone
010-67096523
Ext
100050
Email
caoyong6@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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