NCT03306823

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

May 31, 2017

Last Update Submit

October 10, 2017

Conditions

Cerebral AneurysmArteriovenous Malformations

Keywords

Cerebral AneurysmArteriovenous MalformationsHybrid operationAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Intraoperative blood loss

    During the surgery

Study Arms (2)

aneurysm

For cerebral aneurysm with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.

arteriovenous malformations

For arteriovenous malformations with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients undergoing hybird surgery.

You may not qualify if:

  • Poor general condition , severe primary disease, surgical contraindications
  • Patient or family refused surgery
  • Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
  • Combined with other hemorrhagic cerebrovascular disease
  • Combined with malignant brain tumor
  • Perinatal, Pregnancy
  • Patients unwilling to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Intracranial AneurysmArteriovenous Malformations

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yong Cao, Doctor

CONTACT

010-67096510caoyong6@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal

Study Record Dates

First Submitted

May 31, 2017

First Posted

October 11, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2020

Study Completion

August 1, 2021

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)