Last updated: April 7, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Thyroid Disorders
Stroke
Brain Injury
Treatment
Euthyrox
Clinical Study ID
NCT06353555
PUMCH-20240311
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Admittance of neurocritical patients to the Neurological Intensive Care Unit (NICU)with a Glasgow Coma Scale (GCS) score of 3-8 and supratentorial hematoma volume >30ml. The disease is limited to spontaneous intracerebral hemorrhage (supratentorialbrain parenchyma, with or without hematoma rupture into the ventricle).
- Age: 18-80 years old.
- Onset within 24 hours.
- Free T3 < 1.80 pg/ml or free T4 < 0.81 ng/dl within 7 days of onset, with or withoutTSH < 0.38 μIU/ml. (Specifically according to the critical values of different centerlaboratories' abnormal ranges).
- Emergency head CT scan completed within 24 hours of onset.
Exclusion
Exclusion Criteria:
- Organic thyroid lesions (subacute thyroiditis, chronic thyroiditis,post-thyroidectomy, thyroid radiation, hyperthyroidism), history of thyroid hormoneoral replacement therapy within the past month.
- Sella region lesions.
- Baseline CT indicates irreversible brain herniation, expected survival period <30days.
- Severe systemic multiple injuries outside the nervous system.
- Pregnant women.
- Acute or chronic heart failure, arrhythmias, myocardial disease.
- Only TSH levels decrease while free T3 and free T4 levels remain normal.
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Euthyrox
Phase:
Study Start date:
October 11, 2023
Estimated Completion Date:
December 31, 2025
Connect with a study center
Peking union medical college hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
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