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Prehospital COOLing 1 (PreCOOL 1) (PreCOOL)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Dr. Sven Poli, University Hospital Heidelberg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669408
First Posted: August 21, 2012
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg
  Purpose
Elevated body temperature was shown to be associated with worse outcome in acute stroke patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital cooling with cold infusions in stroke patients.

Condition Intervention Phase
Stroke Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)

Further study details as provided by Dr. Sven Poli, University Hospital Heidelberg:

Primary Outcome Measures:
  • Tympanic Temperature [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ]
    Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: single measurement at arrival in the ER ]
    Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.

  • Vital parameters [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ]
    Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.

  • Tolerability [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ]
    Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".

  • Safety [ Time Frame: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min ]
    Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, cardiac decompensation), dose of co-medication needed (e.g. antihypertensives, diuretics, anti-shivering medication), number of patients with oral temperature < 36°C and safety laboratory (Na, K, creatinine, urea, GFR, CK, CK-MB, troponin T, glucose, blood count, INR, aPTT, TT, NT-ProBNP and D-dimer)


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cold infusions
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
No Intervention: Control group
Best medical treatment following international stroke guidelines

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected stroke
  • Symptom onset ≤ 7 days
  • Tympanic temperature ≥ 36.7°C
  • Informed consent by the patient
  • Age ≥ 18 years

Exclusion Criteria:

  • Severe cardiac insufficiency (NYHA ≥ III)
  • New anisocoria, severe nausea, vomiting or headache
  • High-grade heart valve stenosis or insufficiency
  • Acute pulmonary embolism
  • Acute myocardial infarction
  • Threatening ventricular dysrhythmia
  • 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)
  • Severe renal insufficiency with reduced diuresis
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669408


Contacts
Contact: Sven Poli, Dr. med. 0049 6221 56 ext 0 sven.poli@med.uni-heidelberg.de
Contact: Erik Popp, PD Dr. med. 0049 6221 56 ext 0 erik.popp@med.uni-heidelberg.de

Locations
Germany
Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Sven Poli, Dr. med.    0049 6221 56 ext 0    sven.poli@med.uni-heidelberg.de   
Contact: Erik Popp, PD Dr. med.    0049 6221 56 ext 0    erik.popp@med.uni-heidelberg.de   
Principal Investigator: Sven Poli, Dr. med.         
Principal Investigator: Erik Popp, PD Dr. med.         
Sub-Investigator: Christian Hametner, Dr. med.         
Sub-Investigator: Jan Purrucker, Dr. med.         
Sub-Investigator: Miriam Priglinger, Dr. med.         
Sub-Investigator: Maxim Bartz         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Sven Poli, Dr. med. University Hospital Heidelberg
Principal Investigator: Erik Popp, PD Dr. med. University Hospital Heidelberg
  More Information

Responsible Party: Dr. Sven Poli, Dr. Sven Poli, Consultant Neurologist, Principical Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01669408     History of Changes
Other Study ID Numbers: PreCOOL 1
First Submitted: August 14, 2012
First Posted: August 21, 2012
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Dr. Sven Poli, University Hospital Heidelberg:
ischemic stroke
hemorrhagic stroke
prehospital cooling
induction of cooling
ambulance
emergency room
cold infusions
hypothermia
normothermia

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions


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