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 University Hospital Heidelberg.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg Identifier:
First received: August 14, 2012
Last updated: June 21, 2013
Last verified: June 2013
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
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: 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 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


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

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
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Please refer to this study by its identifier: NCT01669408

Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
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 Identifier: NCT01669408     History of Changes
Other Study ID Numbers: PreCOOL 1 
Study First Received: August 14, 2012
Last Updated: June 21, 2013

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

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions processed this record on January 23, 2017