Prehospital COOLing 1 (PreCOOL 1)

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cold infusions<br>Infusion of 1L cold crystalloid solution (4°C) over 15 minutes | Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution<br>* Infusion of 1L cold crystalloid solution (4°C) over 15 minutes<br>|
| No Intervention: Control group<br>Best medical treatment following international stroke guidelines | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, hemorrhagic stroke, prehospital cooling, induction of cooling, ambulance, emergency room, cold infusions, hypothermia, normothermia