Therapeutic Hypothermia in Acute Ischemic Stroke (THAIS)

A randomized controlled trial in ischemic stroke patients with successful endovascular recanalization of therapeutic hypothermia versus standard care using radiological stroke growth as primary outcome and secondary clinical outcomes

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000071628

Acronym

THAIS

Enrollment

Registered

2014-01-21

Start date

2015-09-22

Completion date

2019-07-13

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Hypothermia has great promise as a cytoprotective therapy after stroke given clinical benefit in other brain injury scenarios and animal models of stroke. THAIS is a pilot randomized trial of hypothermia (cooling) versus standard care that focuses on patients with major stroke who have undergone rapid, successful recanalization. This group often demonstrates initial improvement in brain imaging (diffusion MRI) followed by later re-appearance of the lesion which likely reflects a secondary injury. If hypothermia can reduce this secondary injury it has great potential to improve patient outcomes after severe stroke – a patient group that currently have very few treatment options.

Interventions

Therapeutic hypothermia - cooling to 33deg C for 48hr using initial chilled intravenous saline and maintenance external cooling blankets. Subsequent slow rewarming over ~12hr regulated by the blanket.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with ischaemic stroke who have undergone successful (TICI 2b/3) endovascular recanalization and are being cared for in intensive care Informed consent from patient, person responsible or procedural authorization as approved by HREC Possibility to start hypothermia within 6 hours of stroke onset

Exclusion criteria

Metallic foreign bodies or severe claustrophobia precluding MRI Severe co-morbidity or dementia (pre-stroke modified Rankin Scale 4-5) Clinical diagnosis of pneumonia or other sepsis at baseline Bradycardia <40bpm at baseline Skin damage (e.g., inflammation, burns, injuries, ulcerations, hives, rash) at the sites intended to be used for cooling Contraindication to sedation and intubation Current participation in another interventional clinical trial

Outcome results