Prehospital COOLing 1 (PreCOOL 1)

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Heidelberg
• Treatments: Pharmaceutical Solutions

Criteria

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