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Prehospital COOLing 1 (PreCOOL 1) (PreCOOL)

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring ischemic stroke, hemorrhagic stroke, prehospital cooling, induction of cooling, ambulance, emergency room, cold infusions, hypothermia, normothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rescue service, Dept. of Anesthesiology, University Hospital HeidelbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Cold infusions

Control group

Arm Description

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

Best medical treatment following international stroke guidelines

Outcomes

Primary Outcome Measures

Tympanic Temperature
Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.

Secondary Outcome Measures

Efficacy
Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.
Vital parameters
Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.
Tolerability
Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".
Safety
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)

Full Information

First Posted
August 14, 2012
Last Updated
June 21, 2013
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT01669408
Brief Title
Prehospital COOLing 1 (PreCOOL 1)
Acronym
PreCOOL
Official Title
A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
ischemic stroke, hemorrhagic stroke, prehospital cooling, induction of cooling, ambulance, emergency room, cold infusions, hypothermia, normothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold infusions
Arm Type
Active Comparator
Arm Description
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Best medical treatment following international stroke guidelines
Intervention Type
Drug
Intervention Name(s)
Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Intervention Description
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Primary Outcome Measure Information:
Title
Tympanic Temperature
Description
Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
Time Frame
from randomization (prehospital) until arrival in the ER, an expected average of 45min
Secondary Outcome Measure Information:
Title
Efficacy
Description
Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.
Time Frame
single measurement at arrival in the ER
Title
Vital parameters
Description
Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.
Time Frame
from randomization (prehospital) until arrival in the ER, an expected average of 45min
Title
Tolerability
Description
Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".
Time Frame
from randomization (prehospital) until arrival in the ER, an expected average of 45min
Title
Safety
Description
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)
Time Frame
from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Poli, Dr. med.
Phone
0049 6221 56
Ext
0
Email
sven.poli@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Erik Popp, PD Dr. med.
Phone
0049 6221 56
Ext
0
Email
erik.popp@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Popp, PD Dr. med.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
Phone
0049 6221 56
Ext
0
Email
sven.poli@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Erik Popp, PD Dr. med.
Phone
0049 6221 56
Ext
0
Email
erik.popp@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
First Name & Middle Initial & Last Name & Degree
Erik Popp, PD Dr. med.
First Name & Middle Initial & Last Name & Degree
Christian Hametner, Dr. med.
First Name & Middle Initial & Last Name & Degree
Jan Purrucker, Dr. med.
First Name & Middle Initial & Last Name & Degree
Miriam Priglinger, Dr. med.
First Name & Middle Initial & Last Name & Degree
Maxim Bartz

12. IPD Sharing Statement

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Prehospital COOLing 1 (PreCOOL 1)

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