Prehospital COOLing 1 (PreCOOL 1)

University Hospital Heidelberg40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionDRUG

Infusion of 1L cold crystalloid solution (4°C) over 15 minutes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg

Heidelberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Tympanic Temperature

Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.

Time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min

Secondary Outcomes

Efficacy

Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.

Time frame: single measurement at arrival in the ER

Vital parameters

Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.

Time frame: 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".

Time frame: 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)

Time frame: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min

Central Contacts

Sven Poli, Dr. med.

CONTACT

0049 6221 56 sven.poli@med.uni-heidelberg.de

Erik Popp, PD Dr. med.

CONTACT

0049 6221 56 erik.popp@med.uni-heidelberg.de

Data from ClinicalTrials.gov

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