Clinical trial · Interventional
Mild Hypothermia in Acute Ischemic Stroke
Mild Hypothermia in Acute Ischemic Stroke After Thrombolytic Therapy: a Prospective,Open,Randomized,Single-center,Safety and Feasibility Study
NCT00987922CI-TRIAL-00005513completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with acute ischemic stroke.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Ischemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypothermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypothermia
- interventionNames
- Device: Hypothermia
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period.
- timeFrame
- 12 hours
Secondary outcomes (5)
- measure
- The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to Meilahti protocol * NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total NIHSS score * Symptom onset within 6 hour Exclusion Criteria: * Platelet count \< 75,000/mm3 * Known coagulopathy (INR spontaneously \>1.5) * Hemodynamical unstability * Recent history of angina pectoris or acute myocardial infarction * Sepsis within 72 hours * Pregnancy * Pre-existing neurological disability with modified Rankin Scale Score\>2 * Known allergy or intolerance to buspirone, dexmedetomidine, meperidine * Intracranial hemorrhage in brain CT scan * Intracranial mass lesion (i.e., abscess, tumor, or infection) * Participation in an other therapy trial within last 3 months * Hypothermia- treatment cannot be initiated within 6 hours of symptom onset * Protocol violation in thrombolytic therapy * Any condition where researchers assume that the patient is not suitable (must be reasoned)
References
Publications (1)
- DERIVEDPiironen K, Tiainen M, Mustanoja S, Kaukonen KM, Meretoja A, Tatlisumak T, Kaste M. Mild hypothermia after intravenous thrombolysis in patients with acute stroke: a randomized controlled trial. Stroke. 2014 Feb;45(2):486-91. doi: 10.1161/STROKEAHA.113.003180. Epub 2014 Jan 16. PMID 24436240