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

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ClinicalTrials.gov Identifier: NCT03306836
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborators:
Tang-Du Hospital
Kunming Medical University
First Affiliated Hospital of Fujian Medical University
Nanjing PLA General Hospital
Fujian Medical University Union Hospital
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

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

Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Arteriovenous Malformations Drug: Heparin Sodium Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Heparin Sodium
Infused with 5000 IU of Heparin Sodium

Drug: Heparin Sodium
Infusion Heparin Sodium at a rate of 18 IU / kg.h
Active Comparator: Low dose group of Heparin Sodium
infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.
 Drug: Heparin Sodium
Infusion Heparin Sodium at a rate of 18 IU / kg.h


Outcome Measures
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Primary Outcome Measures :
  1. Changes in activated coagulation time 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 ]
    Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.


Secondary Outcome Measures :
  1. Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery [ Time Frame: 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.

  2. Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery [ Time Frame: From the beginning of surgery to 48 hours after surgery ]
    Ischemia event include Cerebral infarction and transient ischemic attack.

  3. Intraoperative blood loss [ Time Frame: From the beginning of surgery to 48 hours after surgery ]
    All the blood lost during the surgery should be collected and measured.


Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306836


Contacts
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Contact: Yong Cao, Doctor 010-67096510 caoyong6@hotmail.com

Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, M.D.    010-67096523 ext 100050    caoyong6@hotmail.com   
Principal Investigator: Yong Cao, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
Tang-Du Hospital
Kunming Medical University
First Affiliated Hospital of Fujian Medical University
Nanjing PLA General Hospital
Fujian Medical University Union Hospital
More Information
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Responsible Party: Dr. Yong Cao, principal, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03306836    
Other Study ID Numbers: 2016YFC1301800-2
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Yong Cao, Beijing Tiantan Hospital:
Hybrid operation
Cerebral Aneurysm
Arteriovenous Malformations
Anticoagulation
Additional relevant MeSH terms:
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Hemangioma
Intracranial Aneurysm
Aneurysm
Arteriovenous Malformations
Congenital Abnormalities
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
 Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action