NCT00987922

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

4.2 years

First QC Date

September 30, 2009

Last Update Submit

September 17, 2011

Conditions

Brain Ischemia

Keywords

StrokeAcuteInfarctionIschemicThrombolysisMildHypothermia

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period.

    12 hours

Secondary Outcomes (5)

  • The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events

    14 days

  • All-cause mortality during acute phase (7 days), 1 month, and 3 month follow-up; and readmission to hospital for any reason within 3-months.

    3 months

  • The proportion of modified Rankin Scale-responders (mRS 0-2), Barthel Index, NIHSS, Glasgow Outcome Scale

    3 months

  • Neuropsychological tests

    3 months

  • Size of infarction in MRI, and grading of the possible hemorrhagic transformation according to SITS scale (MRI includes scout images, DWI, T1, T2, FLAIR, T2*, and MR angiography)

    3-7 days

Study Arms (2)

Hypothermia

EXPERIMENTAL
Device: Hypothermia

Control

NO INTERVENTION

Interventions

HypothermiaDEVICE

Hypothermia to core temperature of 35C for 12 hours, rewarming rate 0.2C until the patient reaches 36.8C

Hypothermia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Piironen 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: 24436240DERIVED

MeSH Terms

Conditions

Brain IschemiaStrokeInfarctionIschemiaLymphoma, FollicularHypothermia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBody Temperature ChangesSigns and Symptoms

Study Officials

  • Markku Kaste, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

July 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 20, 2011

Record last verified: 2011-09