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Impact of cooling on patients with acute stroke

Impact of hypothermia on final outcome of patients with acute stroke: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181105041565N1
Enrollment
70
Registered
2019-04-23
Start date
2018-07-01
Completion date
Unknown
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke. Vascular syndromes of brain in cerebrovascular diseases

Interventions

Intervention 1: Intervention group: Group A, that hypothermia is performed through the cooling device (Helmets) which is placed on the patient's head. Intervention 2: Control group: Group B that patie

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Having a hemorrhagic or ischemic stroke Age over 18 years old Informed consent form signed by the patient or his/her representative Not having severe heart failure - Grade 2 and 3 based on cardiologist diagnosis Absence of pulmonary embolism or acute myocardial infarction Absence of any cardiac arrhythmia or ventricular or atrioventricular block in the ECG Absence of acute or chronic sinusitis or current skull bone fracture Not getting septicemia or bacteremia or severe blood infection at the admission time Not having fever above 38.5 ° C when admitted Absence of known blood diseases with increase the risk of thrombosis such as cryoglobulinemian, cold agglutination, or sickle cell anemia Absence of known spastic venous complications, such as Raynaud's disease, or thromboangiitis obliterans Weight less than 120 kg

Exclusion criteria

Exclusion criteria: Death in less than 24 hours after admission Patient or legal guardian requisition for leaving the study Incidence of unwanted side effects includes intolerance, seizure, shivering, or physician discretion Incidence of cardiac dysrhythmias

Design outcomes

Primary

MeasureTime frame
Level of patient alertness. Timepoint: A 72-hour period. Method of measurement: FOUR Score Scale: A tool that measures patient's alertness and level of consciousness.;Predict the patient's recovery rate. Timepoint: A 72-hour period. Method of measurement: APACHE Scale that is used to measure the prognosis and recovery rate of the patients in critical care unit.;Health level of patients. Timepoint: A 72-hour period. Method of measurement: The NIHSS scale a tool is used to health level of patients with stroke.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbbas Rozbahani

Islamic Azad University

abbas.rozbahanaa@yahoo.com+98 44 3272 2045

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026