NCT03306836

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Aneurysm
• Arteriovenous Malformations

Interventions

Type	Name	Description
DRUG	Heparin Sodium	Infused with 5000 IU of Heparin Sodium
DRUG	Heparin Sodium	Infusion Heparin Sodium at a rate of 18 IU / kg.h

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-09-01
• Completion: 2021-08-01
• First posted: 2017-10-11
• Last updated: 2017-10-11

Locations

1 site across 1 country: China