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StrokePhase 3GOLIATHNCT02317237

"GOLIATH" - General Or Local Anaestesia in Intra Arterial THerapy

A Phase 3 study testing Local anesthesia in people with Stroke and Anesthesia, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients suffering a stroke with a large vessel occlusion is often treated intra veneous thrombolyse and on top of that also intra arterial therapy. It is unknown what form of anaestesia is best during intra arterial therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Anesthesia, Cerebral Revascularization
What is being tested?
Local anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteDenmark
Study dates
8 Mar 2015to 2 May 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NIHSS>10
  • mRS=<2
  • groin puncture<6hours from stroke onset
  • occlusion of ICA, ICA-T, M1, M2

Who cannot join

  • MRI contraindications
  • GCS<9
  • intubated prior to arrival
  • posterior circulation stroke
  • allergy to anestetics

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

About this study

Official title: Anaesthetic Strategy During Endovascular Therapy: General Anaesthesia or Conscious Sedation ?

Patients suffering a stroke with a large vessel occlusion is often treated intra veneous thrombolyse and on top of that also intra arterial therapy. It is unknown what form of anaestesia is best during intra arterial therapy. The investigators will randomize these patients between general anaestesia and local anaestesia. Outcome will be growth of the ischemic lesion as judged on an MRI scan.

Being tested
Local anesthesia
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local anesthesiaProcedure or surgery

    Conscious sedation

Study groups in NCT02317237
Study groupRoleWhat they receive
General AnesthesiaNo interventionThe patients, who will receive general anesthesia during intervention
Local AnesthesiaExperimentalThe patients, who will receive local anesthesia/conscious sedation during intervention
Receives: Procedure: Local anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth of DWI lesion

    Measured: 48-72 hours

Secondary outcomes (3)

  1. Time from arrival to groin puncture and recanalization

    Measured: 1-2 hours

  2. Blood pressure during intervention

    Measured: 1-2 hours

  3. Modified Rankin Score

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2014 (estimated)
  2. Study start8 Mar 2015
  3. Primary completion2 May 2017
  4. Study completion2 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02317237
Sponsor's protocol ID
GOLIATH
Acronym
GOLIATH
Status last verified
Nov 2015
First submitted
4 Dec 2014
Last updated
3 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Brekenfeld C, Mattle HP, Schroth G. General is better than local anesthesia during endovascular procedures. Stroke. 2010 Nov;41(11):2716-7. doi: 10.1161/STROKEAHA.110.594622. Epub 2010 Oct 7. No abstract available.

    PubMed 20930156

  • Gupta R. Local is better than general anesthesia during endovascular acute stroke interventions. Stroke. 2010 Nov;41(11):2718-9. doi: 10.1161/STROKEAHA.110.596015. Epub 2010 Oct 7. No abstract available.

    PubMed 20930153

  • Froehler MT, Fifi JT, Majid A, Bhatt A, Ouyang M, McDonagh DL. Anesthesia for endovascular treatment of acute ischemic stroke. Neurology. 2012 Sep 25;79(13 Suppl 1):S167-73. doi: 10.1212/WNL.0b013e31826959c2.

    PubMed 23008394

  • Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15.

    PubMed 20395617

  • Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.

    PubMed 35857365

  • Sorensen LH, Speiser L, Karabegovic S, Yoo AJ, Rasmussen M, Sorensen KE, Simonsen CZ. Safety and quality of endovascular therapy under general anesthesia and conscious sedation are comparable: results from the GOLIATH trial. J Neurointerv Surg. 2019 Nov;11(11):1070-1072. doi: 10.1136/neurintsurg-2019-014712. Epub 2019 Mar 29.

    PubMed 30926686

  • Rasmussen M, Espelund US, Juul N, Yoo AJ, Sorensen LH, Sorensen KE, Johnsen SP, Andersen G, Simonsen CZ. The influence of blood pressure management on neurological outcome in endovascular therapy for acute ischaemic stroke. Br J Anaesth. 2018 Jun;120(6):1287-1294. doi: 10.1016/j.bja.2018.01.039. Epub 2018 Mar 28.

    PubMed 29793595

  • Simonsen CZ, Yoo AJ, Rasmussen M, Sorensen KE, Leslie-Mazwi T, Andersen G, Sorensen LH. Magnetic Resonance Imaging Selection for Endovascular Stroke Therapy: Workflow in the GOLIATH Trial. Stroke. 2018 Jun;49(6):1402-1406. doi: 10.1161/STROKEAHA.118.021038. Epub 2018 May 8.

    PubMed 29739917

  • Simonsen CZ, Yoo AJ, Sorensen LH, Juul N, Johnsen SP, Andersen G, Rasmussen M. Effect of General Anesthesia and Conscious Sedation During Endovascular Therapy on Infarct Growth and Clinical Outcomes in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):470-477. doi: 10.1001/jamaneurol.2017.4474.

    PubMed 29340574

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Local anesthesia in people with Stroke and Anesthesia, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth of DWI lesion (time frame: 48-72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02317237, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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