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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03306823
Other study ID # 2016YFC1301800-Anticoagulation
Secondary ID
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
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 556
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

Study Design


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 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. During the surgery
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