StrokePhase 2PreCOOLNCT01669408
Prehospital COOLing 1 (PreCOOL 1)
A Phase 2 study testing Cold crystalloid infusions, 0.9%NaCl or Ringer's solution in people with Stroke, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected stroke
- Symptom onset ≤ 7 days
- Tympanic temperature ≥ 36.7°C
- Informed consent by the patient
- Age ≥ 18 years
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg
Heidelberg, 69120
Sven Poli, Dr. med., 0049 6221 56 ext. 0, sven.poli@med.uni-heidelberg.de
Erik Popp, PD Dr. med., 0049 6221 56 ext. 0, erik.popp@med.uni-heidelberg.de
About this study
Official title: A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
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.
- Conditions
- Stroke
- Being tested
- Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
- Keywords
- ischemic stroke, hemorrhagic stroke, prehospital cooling, induction of cooling, ambulance, emergency room, cold infusions, hypothermia, normothermia
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Emergencies, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionDrug
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Cold infusions | Active comparator | Infusion of 1L cold crystalloid solution (4°C) over 15 minutes Receives: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution |
| Control group | No intervention | Best medical treatment following international stroke guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic Temperature
Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
Measured: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Secondary outcomes (4)
Efficacy
Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER.
Measured: single measurement at arrival in the ER
Vital parameters
Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.
Measured: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Tolerability
Tolerability outcome measures include the Bedside Shivering Assessment Scale (BSAS) and a 10 point visual analog scale to assess "feeling cold" and "shivering".
Measured: from randomization (prehospital) until arrival in the ER, an expected average of 45min
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)
Measured: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sven Poli, University Hospital Heidelberg
- Investigators
- Sven Poli, Dr. med., Principal investigator, University Hospital HeidelbergErik Popp, PD Dr. med., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669408
- Sponsor's protocol ID
- PreCOOL 1
- Acronym
- PreCOOL
- Status last verified
- Jun 2013
- First submitted
- 14 Aug 2012
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
- ClinicalTrials.gov ID
- NCT01669408
- Acronym / sponsor ID
- PreCOOL / PreCOOL 1
- Conditions
- Stroke
- Keywords
- ischemic stroke, hemorrhagic stroke, prehospital cooling, induction of cooling, ambulance, emergency room, cold infusions, hypothermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold infusions | Active comparator | Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionInfusion of 1L cold crystalloid solution (4°C) over 15 minutes |
| Control group | No intervention | –Best medical treatment following international stroke guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suspected stroke
- Symptom onset ≤ 7 days
- Tympanic temperature ≥ 36.7°C
- Informed consent by the patient
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionInfusion of 1L cold crystalloid solution (4°C) over 15 minutes | Drug | Cold infusions |
Primary outcome
Tympanic Temperature
Time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
4 secondary outcomes
Efficacy
Time frame: single measurement at arrival in the ER
Vital parameters
Time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Tolerability
Time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Safety
Time frame: from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Heidelberg HYPOthermia 24/7 - Research group, information and contactsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Poli, Dr. med. principal investigator
University Hospital Heidelberg
Erik Popp, PD Dr. med. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cold crystalloid infusions, 0.9%NaCl or Ringer's solution in people with Stroke, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Poli, Dr. med. (0049 6221 56 ext. 0, sven.poli@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tympanic Temperature (time frame: from randomization (prehospital) until arrival in the ER, an expected average of 45min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.