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Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca

About this trial

The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.

This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).

The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1)

Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis)

Informed consent obtained from patient or patient's next of kin, or emergency consent procedure

Disqualifiers

Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive.

Vomiting upon stroke onset.

History of glaucoma.

History or imaging findings of intracranial hypertension of any aetiology

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEAD DOWN TILT -10° to -15°

    Procedure/Surgery

    Head down tilt -10° to -15° (HDT15) is a positional therapy consisting of tilting the patient with the head -10° to -15° degrees below the rest of the body. Application of HDT15 will not delay usual care. The standard in-hospital patient pathway, including transfer from neuroimaging room to the angiography suite and the required procedural steps of MT, will allow sufficient time for the application of HDT15. HDT15 duration is expected to be at least 30 minutes (estimated time 30 to 90 minutes), from start to the assessment of the primary efficacy endpoint. The actual degree of HDT15 will be a range between -10° to -15°, depending on the angiographic system of each clinical site, but it will be maintained at -15° during the Emergency Room phase which is expected to account for \>50% of the total application time.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: HEAD DOWN TILT -10° to -15° (HDT15)Experimental treatment 1 intervention
Group B: USUAL POSITIONINGNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Good collateral status

The primary endpoint will be the achievement of good collateral status, i.e. grade 3 or 4 on the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) collateral scale, in the HDT15 versus control group, as seen at the beginning of MT.15 The ASITN/SIR collateral grade will be assessed by a blinded central imaging core lab from the pretreatment diagnostic angiographic runs, routinely performed as the first procedural step of MT.

Time frame
Day 0 (during mechanical thrombectomy)

Secondary outcomes

1

Feasibility of HDT15

proportion of patients randomised to the intervention group who are able to maintain HDT15 during the entire MT procedure

Time frame
Day 0 (in the emergency room and angio suite)
2

Delay to thrombectomy

hospital admission-to-arterial access time (i.e. time to arterial puncture)

Time frame
Day 0 (in the emergency room and angio suite)
3

Vomiting

Proportion of patients presenting one or more episodes of vomiting from randomisation to the completion of MT

Time frame
Day 0 (in the emergency room and angio suite)
4

Early neurological deterioration

Proportion of patients who had increase of ≥4 points on the NIHSS score within 24±12 hours of the randomisation

Time frame
1 day (24±12 hours)

Other outcomes

Sponsors and contacts

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University of Milano Bicocca

Lead sponsor

Fondazione IRCCS San Gerardo dei Tintori

Collaborator

Azienda Ospedaliero-Universitaria Careggi

Collaborator

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Collaborator

Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

Collaborator

Università degli Studi dell'Aquila

Collaborator

Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

Collaborator

Source ClinicalTrials.gov
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