Cerebral Aneurysm, Arteriovenous Malformations
Conditions
Keywords
Hybrid operation, Cerebral Aneurysm, Arteriovenous Malformations, Anticoagulation
Brief 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.
Interventions
DRUGHeparin Sodium
Infused with 5000 IU of Heparin Sodium
Sponsors
Tang-Du Hospital
Kunming Medical University
First Affiliated Hospital of Fujian Medical University
Nanjing PLA General Hospital
Fujian Medical University Union Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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 activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery | 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. |
Secondary
| 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. |
| 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 | From the beginning of surgery to 48 hours after surgery | All the blood lost during the surgery should be collected and measured. |
Countries
China
Contacts
Primary ContactYong Cao, Doctor
Outcome results
None listed