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Prehospital COOLing 1 (PreCOOL 1) (PreCOOL)

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ClinicalTrials.gov Identifier: NCT01669408
Recruitment Status : Unknown
Verified June 2013 by Dr. Sven Poli, University Hospital Heidelberg.
Recruitment status was:  Recruiting
First Posted : August 21, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg

Tracking Information
First Submitted Date  ICMJE August 14, 2012
First Posted Date  ICMJE August 21, 2012
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01669408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehospital COOLing 1 (PreCOOL 1)
Official Title  ICMJE A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Study Arms  ICMJE
  • Active Comparator: Cold infusions
    Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
    Intervention: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
  • No Intervention: Control group
    Best medical treatment following international stroke guidelines
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01669408
Other Study ID Numbers  ICMJE PreCOOL 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sven Poli, University Hospital Heidelberg
Study Sponsor  ICMJE University Hospital Heidelberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sven Poli, Dr. med. University Hospital Heidelberg
Principal Investigator: Erik Popp, PD Dr. med. University Hospital Heidelberg
PRS Account University Hospital Heidelberg
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP