Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)

Ischemic Stroke Clinical Trial

— HAIS-SE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01665885
• Other study ID #: HAIS-SE
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 13, 2012
• Last updated: February 16, 2015
• Start date: August 2012
• Est. completion date: November 2015

Study information

• Verified date: June 2013
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Ischemia
• Ischemic Stroke
• Stroke
• Thrombolysis

Intervention

Device:
• ZOLL Thermogard XP
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.
• BARD/Medivance Arctic Sun 5000
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.

Locations

Country	Name	City	State
Germany	Stroke Unit, Dept. of Neurology, University Hospital Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	ZOLL Circulation, Inc., USA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body core temperature	Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.	0 to 48h	No
Secondary	Efficacy	Secondary efficacy outcome measures include the amount of patients reaching the primary target body core temperature (34°C), the time-frame until reaching 35°C body core temperature, temperature stability during maintenance and rewarming.	0 to 48h	Yes
Secondary	Tolerability	Tolerability outcome measures include a specific Hypothermia Participant Experience Questionnaire (HPEQ) and the Bedside Shivering Assessment Scale (BSAS) plus correlation with skin temperature, EMG and sNIRS.	0 to 48h	No
Secondary	Practicability	Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ).	0 to 48h	No
Secondary	Safety	Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, pneumonia). 0 to 48h: Dose needed of anti-shivering medication, level of sedation (RASS, GCS and BIS), safety laboratory including specific coagulation parameters and monitoring of cerebral auto-regulation including cNIRS and BIS.	0 to d90	Yes

External Links

•   Heidelberg HYPOthermia 24/7 - Research group, information and contacts