A Phase 2 interventional study of Cold crystalloid infusions, 0.9%NaCl or Ringer's solution in Stroke, sponsored by University Hospital Heidelberg. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by University Hospital Heidelberg · Phase 2, Interventional, and Treatment
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Best medical treatment following international stroke guidelines
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
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
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
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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University Hospital Heidelberg