Prehospital COOLing 1 (PreCOOL 1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold infusions

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Control group

Best medical treatment following international stroke guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No