Prehospital COOLing 1 (PreCOOL 1)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014