Prehospital COOLing 1 (PreCOOL 1)
This study is not yet open for participant recruitment.
Verified August 2012 by University Hospital Heidelberg
Sponsor:
University Hospital Heidelberg
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01669408
First received: August 14, 2012
Last updated: August 16, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1) |
Further study details as provided by University Hospital Heidelberg:
Primary Outcome Measures:
- Tympanic Temperature [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ] [ Designated as safety issue: No ]Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
Secondary Outcome Measures:
- Efficacy [ Time Frame: single measurement at arrival in the ER ] [ Designated as safety issue: Yes ]Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.
- Vital parameters [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ] [ Designated as safety issue: Yes ]Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.
- Tolerability [ Time Frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min ] [ Designated as safety issue: Yes ]Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".
- Safety [ Time Frame: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min ] [ Designated as safety issue: Yes ]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)
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cold infusions
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
|
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
|
|
No Intervention: Control group
Best medical treatment following international stroke guidelines
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669408
Contacts
| Contact: Sven Poli, Dr. med. | 0049 6221 56 ext 0 | sven.poli@med.uni-heidelberg.de |
| Contact: Erik Popp, PD Dr. med. | 0049 6221 56 ext 0 | erik.popp@med.uni-heidelberg.de |
Locations
| Germany | |
| Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg | Not yet recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Sven Poli, Dr. med. 0049 6221 56 ext 0 sven.poli@med.uni-heidelberg.de | |
| Contact: Erik Popp, PD Dr. med. 0049 6221 56 ext 0 erik.popp@med.uni-heidelberg.de | |
| Principal Investigator: Sven Poli, Dr. med. | |
| Principal Investigator: Erik Popp, PD Dr. med. | |
| Sub-Investigator: Christian Hametner, Dr. med. | |
| Sub-Investigator: Jan Purrucker, Dr. med. | |
| Sub-Investigator: Miriam Priglinger, Dr. med. | |
| Sub-Investigator: Maxim Bartz | |
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
| Principal Investigator: | Sven Poli, Dr. med. | University Hospital Heidelberg |
| Principal Investigator: | Erik Popp, PD Dr. med. | University Hospital Heidelberg |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Sven Poli, Dr. Sven Poli, Consultant Neurologist, Principical Investigator, University Hospital Heidelberg |
| ClinicalTrials.gov Identifier: | NCT01669408 History of Changes |
| Other Study ID Numbers: | PreCOOL 1 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Heidelberg:
|
ischemic stroke hemorrhagic stroke prehospital cooling induction of cooling ambulance |
emergency room cold infusions hypothermia normothermia |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 23, 2013