Overview

This trial is active, not recruiting.

Conditions ischemic stroke, thrombolysis, hypothermia
Treatments zoll thermogard xp, bard/medivance arctic sun 5000
Phase phase 2
Sponsor University Hospital Heidelberg
Collaborator ZOLL Circulation, Inc., USA
Start date August 2012
End date August 2015
Trial size 60 participants
Trial identifier NCT01665885, HAIS-SE

Summary

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter
zoll thermogard xp ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution). Cooling catheter placement at the earliest 30min after end of thrombolysis.
(Active Comparator)
Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads
bard/medivance arctic sun 5000 BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
(No Intervention)
Best medical treatment following international stroke guidelines

Primary Outcomes

Measure
Body core temperature
time frame: 0 to 48h

Secondary Outcomes

Measure
Efficacy
time frame: 0 to 48h
Tolerability
time frame: 0 to 48h
Practicability
time frame: 0 to 48h
Safety
time frame: 0 to d90

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - Ischemic stroke - Intravenous thrombolysis within 4.5h from symptom onset - Informed consent of the patient - NIHSS score ≥ 2 and ≤ 20 - Age ≥ 18 and ≤ 90 years - Placement of cooling catheter / cooling pads within 6h from symptom onset Exclusion Criteria: - (Expected) intubation (e.g. for interventional treatment) - Pregnancy - Body weight > 120kg - Body height < 150cm - Life-expectancy < 3 months - Fever > 38.5°C at screening - Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia) - Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans) - Possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter - Acute pulmonary embolism - Acute myocardial infarction - Severe cardiac insufficiency (NYHA ≥ III) - Threatening ventricular dysrhythmia - QTc-interval > 450ms - Bradycardia < 50/min - Sick-Sinus-Syndrom - AV-block > I° - Severe infection with bacteremia or sepsis ≤ 72h - Severe renal (GFR < 30ml/min) or liver insufficiency (Child-Pugh C) - Myopathy - Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine. - Treatment with MAO-inhibitors ≤ 14 days - Acute closed-angle glaucoma

Additional Information

Official title HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis
Principal investigator Sven Poli, Dr. med.
Description Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients. HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by University Hospital Heidelberg.