NCT01665885

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

August 13, 2012

Last Update Submit

February 16, 2015

Conditions

Ischemic StrokeThrombolysisHypothermia

Keywords

hypothermiainduction of hypothermianon invasive coolingexternal coolingsurface coolingendovascular coolingcooling catheterstrokeshiveringneuro monitoringcoagulation

Outcome Measures

Primary Outcomes (1)

  • Body core temperature

    Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction.

    0 to 48h

Secondary Outcomes (4)

  • Efficacy

    0 to 48h

  • Tolerability

    0 to 48h

  • Practicability

    0 to 48h

  • Safety

    0 to d90

Study Arms (3)

Endovascular cooling

ACTIVE COMPARATOR

Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter

Device: ZOLL Thermogard XP

Surface cooling

ACTIVE COMPARATOR

Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads

Device: BARD/Medivance Arctic Sun 5000

Control group

NO INTERVENTION

Best medical treatment following international stroke guidelines

Interventions

ZOLL Thermogard XPDEVICE

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.

Also known as: ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA, ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USA
Endovascular cooling
BARD/Medivance Arctic Sun 5000DEVICE

Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.

Also known as: BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA, BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USA
Surface cooling

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • (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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Unit, Dept. of Neurology, University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Ischemic StrokeHypothermiaStrokeThrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Officials

  • Sven Poli, Dr. med.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sven Poli, Consultant Neurologist, Principal Investigator

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

February 18, 2015

Record last verified: 2013-06

Locations

DE(1)