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

Not Applicable

• Conditions: Cerebral Aneurysm; Arteriovenous Malformations
• Interventions: Drug: Heparin Sodium

• Registration Number: NCT03306836
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-05-31
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-10
• Last Update Submitted: 2017-10-10
• Study First Posted: 2017-10-11
• Last Update Posted: 2017-10-11
• Primary Completion: 2020-09
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose group of Heparin Sodium	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.
Low dose group of Heparin Sodium	Heparin Sodium	infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.

Primary Outcome Measures

Name	Time	Method
Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery	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

Name	Time	Method
Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery	From the beginning of surgery to 48 hours after surgery	Ischemia event include Cerebral infarction and transient ischemic attack.
Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery	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.
Intraoperative blood loss	From the beginning of surgery to 48 hours after surgery	All the blood lost during the surgery should be collected and measured.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China