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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03306823

Acronym

EAPCAAMHO1

Enrollment

556

Registered

2017-10-11

Start date

2016-09-30

Completion date

2021-08-31

Last updated

2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Malformations, Cerebral Aneurysm

Keywords

Cerebral Aneurysm, Arteriovenous Malformations, Hybrid operation, Anticoagulation

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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.
Intraoperative blood loss	During the surgery	All the blood lost during the surgery should be collected and measured.

Countries

China

Contacts

Primary ContactYong Cao, Doctor

caoyong6@hotmail.com010-67096510

Outcome results