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

Study Overview
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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.

Official Title
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Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation

Conditions
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Cerebral Aneurysm, Arteriovenous Malformations

Intervention / Treatment
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* Drug: Heparin Sodium
* Drug: Heparin Sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard dose group of Heparin Sodium<br>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<br>* Infused with 5000 IU of Heparin Sodium<br>Drug: Heparin Sodium<br>* Infusion Heparin Sodium at a rate of 18 IU / kg.h<br>|
| Active Comparator: Low dose group of Heparin Sodium<br>infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation. | Drug: Heparin Sodium<br>* Infusion Heparin Sodium at a rate of 18 IU / kg.h<br>|

What is the study measuring?
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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 | 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 | 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 | Ischemia event include Cerebral infarction and transient ischemic attack. | From the beginning of surgery to 48 hours after surgery | 
| Intraoperative blood loss | All the blood lost during the surgery should be collected and measured. | From the beginning of surgery to 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hybrid operation, Cerebral Aneurysm, Arteriovenous Malformations, Anticoagulation