Stroke
Conditions
Keywords
ischemic stroke, hemorrhagic stroke, prehospital cooling, induction of cooling, ambulance, emergency room, cold infusions, hypothermia, normothermia
Brief summary
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.
Interventions
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tympanic Temperature | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 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 | 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 | 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 | 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) |
Countries
Germany
Contacts
Primary ContactSven Poli, Dr. med.
Backup ContactErik Popp, PD Dr. med.
Outcome results
None listed