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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold infusions | Active Comparator | Infusion of 1L cold crystalloid solution (4°C) over 15 minutes |
|
| Control group | No Intervention | Best medical treatment following international stroke guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold crystalloid infusions, 0.9%NaCl or Ringer's solution | Drug | Infusion of 1L cold crystalloid solution (4°C) over 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Secondary efficacy endpoint: Proportion of patients having a oral temperature between 36 and 37.1°C at arrival in the ER. | single measurement at arrival in the ER |
| Vital parameters | Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sven Poli, Dr. med. | Contact | 0049 6221 56 | 0 | sven.poli@med.uni-heidelberg.de |
| Erik Popp, PD Dr. med. | Contact | 0049 6221 56 | 0 | erik.popp@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Sven Poli, Dr. med. | University Hospital Heidelberg | Principal Investigator |
| Erik Popp, PD Dr. med. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D004630 | Emergencies |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077331 | Ringer's Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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". | 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) | from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |