Prehospital COOLing 1 (PreCOOL 1)

Stroke Clinical Trial

— PreCOOL  

Official title:

A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01669408
• Other study ID #: PreCOOL 1
• Status: Recruiting
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: June 21, 2013
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: University Hospital Heidelberg
• Contact: Sven Poli, Dr. med.
• Phone: 0049 6221 56
• Email: sven.poli[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes

Locations

Country	Name	City	State
Germany	Rescue service, Dept. of Anesthesiology, University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Vital parameters	Effects on vital parameters (e.g. HR, ECG, BP, SpO2) are registered.	from randomization (prehospital) until arrival in the ER, an expected average of 45min	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   Heidelberg HYPOthermia 24/7 - Research group, information and contacts