NCT05182619

Brief Summary

the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2022

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

First Submitted

Initial submission to the registry

December 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 10, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 20, 2021

Last Update Submit

December 20, 2021

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • enhancement of cerebral blood flow

    increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound

    one week

Study Arms (2)

ultrasoung guided stellate block

ACTIVE COMPARATOR

stellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow

Procedure: ultrasound-guided stellate ganglion block

nimodipine infusion

ACTIVE COMPARATOR

intravenous nimodipine will be given for enhancement of cerebral blood flow

Procedure: ultrasound-guided stellate ganglion block

Interventions

ultrasound-guided stellate ganglion blockPROCEDURE

under aseptic conditions, using the ultrasound guidance, bilateral stellate ganglion block will be done using bupivacaine and betamethasone mixture, 8 ml volume will be given for each side

nimodipine infusionultrasoung guided stellate block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients more than 18 ys old with isolated head trauma and traumatic brain injury

You may not qualify if:

  • Hemodynamic instability (mean ABP less than 70 mmHg)
  • History of severe systemic disease including cardiopulmonary failure or hepatorenal failure
  • Allergy to local anesthetics
  • Coagulation disorders
  • Abnormal neck structures disturbing normal anatomy as neck tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer os anesthesia and intensive care

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 10, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

January 10, 2022

Record last verified: 2021-12