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

Cerebral Aneurysm Clinical Trial

— EAPCAAMHO2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306836
• Other study ID #: 2016YFC1301800-2
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2017
• Last updated: October 10, 2017
• Start date: September 2016
• Est. completion date: August 2021

Study information

• Verified date: October 2017
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, Doctor
• Phone: 010-67096510
• Email: caoyong6[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: August 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Arteriovenous Malformations
• Cerebral Aneurysm
• Congenital Abnormalities
• Hemangioma
• Intracranial Aneurysm

Intervention

Drug:
• Heparin Sodium
Infused with 5000 IU of Heparin Sodium
• Heparin Sodium
Infusion Heparin Sodium at a rate of 18 IU / kg.h

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	First Affiliated Hospital of Fujian Medical University, Fujian Medical University Union Hospital, Kunming Medical University, Nanjing PLA General Hospital, Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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