Prehospital COOLing 1 (PreCOOL 1)
PreCOOL
A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 stroke
Started Sep 2012
Shorter than P25 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 24, 2013
June 1, 2013
1 year
August 14, 2012
June 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tympanic Temperature
Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
from randomization (prehospital) until arrival in the ER, an expected average of 45min
Secondary Outcomes (4)
Efficacy
single measurement at arrival in the ER
Vital parameters
from randomization (prehospital) until arrival in the ER, an expected average of 45min
Tolerability
from randomization (prehospital) until arrival in the ER, an expected average of 45min
Safety
from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min
Study Arms (2)
Cold infusions
ACTIVE COMPARATORInfusion of 1L cold crystalloid solution (4°C) over 15 minutes
Control group
NO INTERVENTIONBest medical treatment following international stroke guidelines
Interventions
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Eligibility Criteria
You may qualify if:
- Suspected stroke
- Symptom onset ≤ 7 days
- Tympanic temperature ≥ 36.7°C
- Informed consent by the patient
- Age ≥ 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg
Heidelberg, 69120, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sven Poli, Dr. med.
University Hospital Heidelberg
- PRINCIPAL INVESTIGATOR
Erik Popp, PD Dr. med.
University Hospital Heidelberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Sven Poli, Consultant Neurologist, Principical Investigator
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 21, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
June 24, 2013
Record last verified: 2013-06