Prehospital COOLing 1 (PreCOOL 1)

This study is currently recruiting participants.
Verified June 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01669408
First received: August 14, 2012
Last updated: June 21, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Tympanic Temperature [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: August 14, 2012
Last Updated: June 21, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014