Prehospital COOLing 1 (PreCOOL 1) (PreCOOL)

A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg
    • Contact: Sven Poli, Dr. med.; Phone Number: 0049 6221 56; Email: sven.poli@med.uni-heidelberg.de
    • Contact: Erik Popp, PD Dr. med.; Phone Number: 0049 6221 56; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.	single measurement at arrival in the ER
Vital parameters	Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.	from randomization (prehospital) until arrival in the ER, an expected average of 45min
Tolerability	Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".	from randomization (prehospital) until arrival in the ER, an expected average of 45min
Safety	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)	from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Sven Poli, Dr. med., University Hospital Heidelberg; Principal Investigator: Erik Popp, PD Dr. med., University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: ischemic stroke; hypothermia; hemorrhagic stroke; prehospital cooling; induction of cooling; ambulance; emergency room; cold infusions; normothermia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PreCOOL 1