NCT03306836

Brief Summary

In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.

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
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

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

Hybrid operationCerebral AneurysmArteriovenous MalformationsAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • Changes in activated coagulation time safety coverage rate 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.

    From the beginning of surgery to 48 hours after surgery

Secondary Outcomes (3)

  • 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

  • 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

    From the beginning of surgery to 48 hours after surgery

Study Arms (2)

Standard dose group of Heparin Sodium

EXPERIMENTAL

First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.

Drug: Heparin Sodium

Low dose group of Heparin Sodium

ACTIVE COMPARATOR

infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.

Drug: Heparin Sodium

Interventions

Heparin SodiumDRUG

Infused with 5000 IU of Heparin Sodium

Standard dose group of Heparin Sodium

Eligibility Criteria

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

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

Interventions

Heparin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Yong Cao, Doctor

CONTACT

010-67096510caoyong6@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
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)