Intracerebral HemorrhageNCT06353555
Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage
A study testing Euthyrox in people with Intracerebral Hemorrhage and Low T3 Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Low T3 Syndrome, Neurocritical Care
- What is being tested?
- Euthyrox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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 without TSH < 0.38 μIU/ml. (Specifically according to the critical values of different center laboratories' abnormal ranges).
- Emergency head CT scan completed within 24 hours of onset.
Who cannot join
- Organic thyroid lesions (subacute thyroiditis, chronic thyroiditis, post-thyroidectomy, thyroid radiation, hyperthyroidism), history of thyroid hormone oral replacement therapy within the past month.
- Sella region lesions.
- Baseline CT indicates irreversible brain herniation, expected survival period <30 days.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Beijing Municipality, 100730
Junji Wei, +8615801056698, weijunji@pumch.cn
About this study
Official title: A Study on the Efficacy of Thyroid Hormone Replacement Therapy for Secondary Hypothyroidism Following Intracerebral Hemorrhage
Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.
Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.
Read more
As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.
The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.
This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism.
- Conditions
- Intracerebral Hemorrhage, Low T3 Syndrome, Neurocritical Care, Hormone Replacement Therapy
- Being tested
- Euthyrox
- Medical subject headings
- Cerebral Hemorrhage, Euthyroid Sick Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuthyroxDrug
Upon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing <75kg) or 150μg qd (for individuals weighing >75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days.
EuthyroxDrug
Patient will not receive the oral levothyroxine sodium tablets.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid hormone replacement therapy | Experimental | Upon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing <75kg) or 150μg qd (for individuals weighing >75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days. Receives: Drug: Euthyrox |
| Non-thyroid hormone replacement therapy | Sham comparator | Patients will not receive the oral levothyroxine sodium tablets. Receives: Drug: Euthyrox |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, heart rate in beat per minute
Measured: Day1、2、3、5、7（ 9:00 17:00 21:00）
cerebral blood flow dynamics
Cerebral blood volume in ml/100g; cerebral blood flow in ml/(100g·min)
Measured: Day 7
Whether to use vasoactive vasopressors
Blood pressure in mmHg before and after using vasoactive vasopressors
Measured: Day 1 to 7
neurological function
modified Ranking Scale score (0 to 6 score, from better to worse)
Measured: in 90 days
Secondary outcomes (2)
Days of the patients received intensive care
Measured: From date of randomization until the date of first documented progression or date of discharge from any cause, whichever came first, assessed up to 12 months
Mechanical ventilation time
Measured: From date of randomization until the date of first documented progression or date of discharge from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start11 Oct 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Junji, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353555
- Sponsor's protocol ID
- PUMCH-20240311
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy of Thyroid Hormone Replacement Therapy for Secondary Hypothyroidism Following Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06353555
- Acronym / sponsor ID
- PUMCH-20240311
- Conditions
- Intracerebral Hemorrhage, Low T3 Syndrome, Neurocritical Care, Hormone Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.
Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.
As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.
The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.
This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid hormone replacement therapy | Experimental | Drug: EuthyroxUpon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing <75kg) or 150μg qd (for individuals weighing >75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days. |
| Non-thyroid hormone replacement therapy | Sham comparator | Drug: EuthyroxPatients will not receive the oral levothyroxine sodium tablets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- 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 without TSH < 0.38 μIU/ml. (Specifically according to the critical values of different center laboratories' abnormal ranges).
- Emergency head CT scan completed within 24 hours of onset.
Key exclusion criteria (7 listed)
- Organic thyroid lesions (subacute thyroiditis, chronic thyroiditis, post-thyroidectomy, thyroid radiation, hyperthyroidism), history of thyroid hormone oral replacement therapy within the past month.
- Sella region lesions.
- Baseline CT indicates irreversible brain herniation, expected survival period <30 days.
- Severe systemic multiple injuries outside the nervous system.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EuthyroxUpon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing <75kg) or 150μg qd (for individuals weighing >75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days. | Drug | Thyroid hormone replacement therapy |
| EuthyroxPatient will not receive the oral levothyroxine sodium tablets. | Drug | Non-thyroid hormone replacement therapy |
Primary outcome
blood pressure
Time frame: Day1、2、3、5、7（ 9:00 17:00 21:00）
Systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, heart rate in beat per minute
cerebral blood flow dynamics
Time frame: Day 7
Cerebral blood volume in ml/100g; cerebral blood flow in ml/(100g·min)
Whether to use vasoactive vasopressors
Time frame: Day 1 to 7
Blood pressure in mmHg before and after using vasoactive vasopressors
neurological function
Time frame: in 90 days
modified Ranking Scale score (0 to 6 score, from better to worse)
2 secondary outcomes
Days of the patients received intensive care
Time frame: From date of randomization until the date of first documented progression or date of discharge from any cause, whichever came first, assessed up to 12 months
Mechanical ventilation time
Time frame: From date of randomization until the date of first documented progression or date of discharge from any cause, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Euthyrox in people with Intracerebral Hemorrhage and Low T3 Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junji Wei (15801056698 ext. 86, weijunji@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: Day1、2、3、5、7（ 9:00 17:00 21:00）). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.