- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03306836
Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 (EAPCAAMHO2)
October 10, 2017 updated by: Dr. Yong Cao, Beijing Tiantan Hospital
Multi-center,Single Blind,Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
408
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yong Cao, Doctor
- Phone Number: 010-67096510
- Email: caoyong6@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Yong Cao, M.D.
- Phone Number: 100050 010-67096523
- Email: caoyong6@hotmail.com
-
Principal Investigator:
- Yong Cao, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Infused with 5000 IU of 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.
|
Infused with 5000 IU of Heparin Sodium
Infusion Heparin Sodium at a rate of 18 IU / kg.h
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the beginning of surgery to 48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the beginning of surgery to 48 hours after surgery
|
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.
|
From the beginning of surgery to 48 hours after surgery
|
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.
|
From the beginning of surgery to 48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
May 31, 2017
First Submitted That Met QC Criteria
October 10, 2017
First Posted (Actual)
October 11, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2017
Last Update Submitted That Met QC Criteria
October 10, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Cardiovascular Abnormalities
- Neoplasms, Vascular Tissue
- Vascular Malformations
- Intracranial Arterial Diseases
- Congenital Abnormalities
- Hemangioma
- Arteriovenous Malformations
- Aneurysm
- Intracranial Aneurysm
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Calcium heparin
Other Study ID Numbers
- 2016YFC1301800-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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