Prehospital COOLing 1 (PreCOOL 1)

Phase 2

• Conditions: Stroke
• Interventions: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

• Registration Number: NCT01669408
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Study Start: 2012-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany