Thyroid hormone replacement for patients with low thyroid levels after brain hemorrhage
A Study on the Efficacy of Thyroid Hormone Replacement Therapy for Secondary Hypothyroidism Following Intracerebral Hemorrhage
This study tests if giving thyroid hormone replacement to patients with low thyroid levels after a brain bleed can help improve their recovery in the intensive care unit.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06353555 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of thyroid hormone replacement therapy in neurocritical patients who have experienced an intracerebral hemorrhage and exhibit low levels of triiodothyronine (T3) and thyroxine (T4). It focuses on patients admitted to the Neurological Intensive Care Unit with severe brain injuries, specifically those with a Glasgow Coma Scale score of 3-8 and significant hematoma volume. The intervention involves administering Euthyrox to assess its efficacy in improving thyroid hormone levels and potentially enhancing patient outcomes in this critical care setting.
Who should consider this trial
Good fit: Ideal candidates are neurocritical patients aged 18-80 with severe intracerebral hemorrhage and low thyroid hormone levels.
Not a fit: Patients with pre-existing thyroid conditions or those who have undergone recent thyroid hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and recovery outcomes for patients with low thyroid hormone levels following brain hemorrhage.
How similar studies have performed: While there is limited research specifically targeting this patient population, previous studies have indicated that low thyroid hormone levels are associated with poor outcomes in critical care settings, suggesting potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 \>30 ml. The disease is limited to spontaneous intracerebral hemorrhage (supratentorial brain parenchyma, with or without hematoma rupture into the ventricle). 2. Age: 18-80 years old. 3. Onset within 24 hours. 4. Free T3 \< 1.80 pg/ml or free T4 \< 0.81 ng/dl within 7 days of onset, with or without TSH \< 0.38 μIU/ml. (Specifically according to the critical values of different center laboratories' abnormal ranges). 5. Emergency head CT scan completed within 24 hours of onset. Exclusion Criteria: 1. Organic thyroid lesions (subacute thyroiditis, chronic thyroiditis, post-thyroidectomy, thyroid radiation, hyperthyroidism), history of thyroid hormone oral replacement therapy within the past month. 2. Sella region lesions. 3. Baseline CT indicates irreversible brain herniation, expected survival period \<30 days. 4. Severe systemic multiple injuries outside the nervous system. 5. Pregnant women. 6. Acute or chronic heart failure, arrhythmias, myocardial disease. 7. Only TSH levels decrease while free T3 and free T4 levels remain normal.
Where this trial is running
Beijing, Beijing
- Peking union medical college hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Junji Wei
- Email: weijunji@pumch.cn
- Phone: 15801056698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.