NCT04949815

Brief Summary

The study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

June 23, 2021

Last Update Submit

June 25, 2021

Conditions

Awareness, AnesthesiaArteriovenous Malformations

Outcome Measures

Primary Outcomes (1)

  • Change in neurological status after surgery including GCS, cranial nerve functions and motor power in all four limbs (according to MRC scale).

    Comparison of pre-operative and post-operative neurological status to assess whether there was net improvement or deterioration. Pre-operative neurological status was assessed at the time of hospital admission and post-operative neurological status was assessed after 10 days of surgery.

    10 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients, irrespective of age and gender, who underwent awake craniotomy under scalp block for resection of brain AVMs at our hospital were reviewed.

You may qualify if:

  • Clinical diagnosis of arteriovenous malformation in brain
  • Awake craniotomy for surgical resection of arteriovenous malformation

You may not qualify if:

  • Patients with incomplete records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74500, Pakistan

Location

MeSH Terms

Conditions

Intraoperative AwarenessArteriovenous Malformations

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 2, 2021

Study Start

April 1, 2018

Primary Completion

December 20, 2019

Study Completion

March 2, 2020

Last Updated

July 2, 2021

Record last verified: 2021-06

Locations

PA(1)