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UnknownNCT03306823

Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

Multi-center, Single-blind, Prospective Cohort Study of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation

Status
Unknown
Phase
Study type
Observational
Enrollment
556 (estimated)
Sponsor
Beijing Tiantan Hospital · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

Summary

In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.

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

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

Source: ClinicalTrials.gov record NCT03306823. Inclusion in this directory is not an endorsement.