Clinical trial NCT03306823: Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1
Official title: Multi-center, Single-blind, Prospective Cohort Study of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Aneurysm
Arteriovenous Malformations
Keywords: Cerebral Aneurysm
Arteriovenous Malformations
Hybrid operation
Anticoagulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Tang-Du Hospital
name: Kunming Medical University
name: First Affiliated Hospital of Fujian Medical University
name: Nanjing PLA General Hospital
name: Fujian Medical University Union Hospital
First posted: 2017-10-11
Enrollment: 556
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators chose the patiens from the Tiantan hospital and other hospitals that participated in this study.The patients diagnosed as cerebral aneurysm and arteriovenous malformations,and take part in hybrid operation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery
timeFrame: From the beginning of surgery to 48 hours after surgery
Secondary outcomes:
measure: Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery
timeFrame: From the beginning of surgery to 48 hours after surgery
measure: Intraoperative blood loss
timeFrame: During the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: