Prehospital COOLing 1 (PreCOOL 1)

University Hospital Heidelberg

Status and phase: Unknown; Phase 2

Conditions: Stroke

Treatments: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01669408

PreCOOL 1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cold infusions

Active Comparator group

Description:

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

Treatment:

Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

Control group

No Intervention group

Description:

Best medical treatment following international stroke guidelines