Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital (RARETBAS)

November 24, 2019 updated by: Tran Nguyen Uyen Dung, University of Medicine and Pharmacy at Ho Chi Minh City
This is a prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known. Although basilar artery occlusion has been reported in 2 per 1000 autopsy cases, basilar artery thrombosis may, in stroke registries, explain as many as 27% of ischemic strokes occurring in the posterior circulation.Various treatments were tried in groups of patients with vertebrobasilar territory infarction but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Study Type

Interventional

Enrollment (Anticipated)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: THANG H Nguyen, MD, PhD
  • Phone Number: 033962478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admit to 115 hospital in 24h of Basilar Artery Occlusion Stroke
  • NIHSS > 4 points

Exclusion Criteria:

  • Patients refuse to participate in studies
  • Patients with contraindication of either rTPA or thromboectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Thromboectomy and rTPA
use thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour
Procedure: Thromboectomy
Thromboectomy in Basilar Artery Occlusion patients
NO_INTERVENTION: rTPA( recombinant tissue plasminogen activator )
use rtpa for patient with basilar artery occlusion stroke in 24 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
Time Frame: 24 hours from admission
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
24 hours from admission
Survival rate in patients with Basilar Artery Occlusion Stroke
Time Frame: 3 months from admission
Survival rate in patients with Basilar Artery Occlusion Stroke
3 months from admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS in patients with Basilar Artery Occlusion Stroke
Time Frame: 3 months from admission
mRS in patients with Basilar Artery Occlusion Stroke
3 months from admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Study Chair: TUAN D Tran, MD, UMP university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 19, 2019

Primary Completion (ANTICIPATED)

November 19, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

November 24, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 24, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yds2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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