Prehospital COOLing 1 (PreCOOL 1)

NCT01669408 — Phase 2, Unknown, 40 participants, University Hospital Heidelberg

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

Registry	NCT01669408, acronym PreCOOL
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	University Hospital Heidelberg (Other)
Conditions	Stroke
Interventions	Cold crystalloid infusions, 0.9%NaCl or Ringer's solution (Drug)
Dates	start 2012-09-01, primary completion 2013-09-01 (estimated), completion 2013-09-01 (estimated), first posted 2012-08-21, last updated 2013-06-24
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cold infusions	Active comparator	Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution	Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Control group	No intervention		Best medical treatment following international stroke guidelines

Cold crystalloid infusions, 0.9%NaCl or Ringer's solution (Drug): Infusion of 1L cold crystalloid solution (4°C) over 15 minutes

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg	Heidelberg	Germany	Recruiting

+Investigators

Sven Poli, Dr. med., Principal investigator, University Hospital Heidelberg
Erik Popp, PD Dr. med., Principal investigator, University Hospital Heidelberg