Edema BrainPhase 4NCT05263167
Reducing Edema After intraCerebral Hemorrhage
A Phase 4 study testing Sodium Aescinate in people with Edema Brain, run by Beijing Tiantan Hospital.
Trial summary
The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edema Brain
- What is being tested?
- Sodium Aescinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to 31 Mar 2025
- Phase
- Phase 4
- 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
- Patients aged between 18-80 years old;
- Spontaneous ICH confirmed by cranial CT;
- Time from onset to randomization within 24 hours;
- Superatentorial ICH;
- Hematoma volume between 10-30 ml (calculated using ABC/2 method);
- Glasgow coma scale (GCS) > 9 on admission;
- informed and consent.
Who cannot join
- Suspected secondary cause of ICH (e.g. aneurysm, vascular malformation, neoplasia, cerebral venous thrombosis, hemorrhagic transformation of recent ischemic stroke, thrombolysis or endovascular treatment, anticoagulation, et al);
- ICH secondary to trauma；
- Primary intraventricular hemorrhage (IVH);
- Signs of herniation, such as progressive decline in consciousness, decreased or disappearance of pupillary light reflection, bilateral pyramidal tract signs, etc;
- Other serious, advanced or terminal illness such that life expectancy is less than one year (e.g. advanced metastatic cancer);
- Severe cardiac insufficiency (NYHA class III or IV);
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- High-risk arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block, bradycardia-related syncope without a pacemaker, etc;
- Severe liver insufficiency; severe liver insufficiency is defined as ALT > 2 times the upper limit of normal or AST greater than 2 times the upper limit of normal;
- Severe renal insufficiency: Severe renal insufficiency is defined as creatinine greater than 1.5 times the upper limit of normal;
- History of severe asthma or chronic obstructive pulmonary disease (COPD);
- History of coagulopathy or systemic bleeding;
- A thrombocyte count below <100 x 10^9/L or leukocytosis < 2 x 10^9/L on admission;
- Patients who plan to undergo surgical intervention before the first administration, including but not limited to hematoma removal (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and ventricular puncture external drainage;
- Patients with preexisting disability of a modified Rankin Scale (mRS) score greater than 2 prior to ICH;
- Unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, affective disorder, etc;
- Women of childbearing potential, pregnant, or breastfeeding at randomization;
- Contraindication to sodium aescinate；
- Participate in other clinical studies within 3 months or are participating in other clinical studies.
Trial locations and contacts
No sites are listed yet.
About this study
The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). The primary outcome is the absolute volume of PHE evaluated based on brain CT image on day 14 after ICH.
Read the detailed description
The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). The primary outcome is the absolute volume of PHE evaluated based on brain CT image on day 14 after ICH. Functional outcome is assessed face to face at 3-month after onset. Meanwhile, central telephone follow-up determines functional outcomes at 3-month after onset. Brain imaging (CT) is performed as part of routine care prior to enrolment. A research CT scan is performed after 24h of symptom onset to assess hematoma expansion; a second research CT scan is performed at 72 hours after onset to assess brain swelling and dynamic change of PHE. The study was approved by the ethics committee of the Beijing Tiantan hospital. The study is conducted according to GCP guidelines.
- Conditions
- Edema Brain
- Being tested
- Sodium Aescinate, Placebo
- Keywords
- edema, intracerebral hemorrhage, sodium aescinate
- Medical subject headings
- Brain Edema, Edema, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium AescinateDrug
Also called Sodium Aescinate for Injection
sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.
PlaceboDrug
Also called 0.9% sodium chloride injection
250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| sodium aescinate group | Experimental | Trial treatment is administered as sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days. Receives: Drug: Sodium Aescinate |
| placebo group | Placebo comparator | Trial treatment is administered as 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute edema volume on day 14 after ICH
Absolute edema volume is based on brain CT image
Measured: on day 14 after ICH
Secondary outcomes (19)
Relative edema volume on day 14 after ICH
Relative edema volume is based on edema volume divided by hematoma volume
Measured: on day 14 after ICH
Absolute edema volume and relative edema volume on 24 ±12 hour and 72±12 hour after ICH symptom onset
absolute edema volume is based on brain CT image；relative edema volume is based on edema volume divided by hematoma volume
Measured: on 24±12 hour and 72±12 hour after ICH symptom onset
Cytotoxic edema on 72 ±12 hour after ICH symptom onset
Cytotoxic edema is based on brain MRI image
Measured: on 72 ±12 hour after ICH symptom onset
Dynamic changes of serum IL-x levels(ng/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Dynamic changes of serum NF-kB levels(ug/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Dynamic changes of serum TNF levels(ng/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Dynamic changes of serum MMPs levels(ug/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Dynamic changes of serum VEGF levels(pg/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Dynamic changes of serum EPO levels(ng/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Dynamic changes of serum angiopoietin-1 levels(pg/ml) within 14 days of symptom onset
The purpose is to evaluate dynamic changes of serum inflammatory factor levels within 14 days of symptom onset
Measured: within 14 days of symptom onset
Change of neurological dysfunction within 14 days of symptom onset
Change of neurological dysfunction within 14 days of symptom onset is based on National institute of health stroke scale(NIHSS）14d-NIHSS enrollment.（The minimum and maximum values of NIHSS is 0 and 42,respectively, higher scores mean a worse outcome.）
Measured: within 14 days of symptom onset
Cognition（MMSE) at 14 days of symptom onset
Cognition is based on Mini-mental State Examination（MMSE）. （The minimum and maximum values of MMSE is 0 and 30,respectively, higher scores mean a better outcome. ）
Measured: at 14 days of symptom onset
Cognition（MoCA) at 14 days of symptom onset
Cognition is based on Montreal Cognitive Assessment（MoCA）. （The minimum and maximum values of MoCA is 0 and 30,respectively, higher scores mean a better outcome.）
Measured: at 14 days of symptom onset
Dependency at 90±7 days after onset
Dependency at 90±7 days after onset Dependency is based on Modified Rankin Scale（mRS ）.
（The minimum and maximum values of mRS is 0 and 5,respectively, higher scores mean a worse outcome.）
Measured: at 90±7 days after onset
Quality of life at 90±7 days after onset
Quality of Life is based on five-level version of EuroQol Five Dimensions Questionnaire（EQ-5D-5L）.
（The scale mainly contains 5 dimensions, including mobility, self-care ability, ability to perform daily activities, pain or discomfort, and anxiety or depression. Each dimension is divided into 5 levels: no difficulty, mild difficulty, moderate difficulty, severe difficulty, extreme difficulty or inability）
Measured: at 90±7 days after onset
Cognition（MMSE） at 90±7 days after onset
Cognition is based on Mini-mental State Examination（MMSE）. （The minimum and maximum values of MMSE is 0 and 30,respectively, higher scores mean a better outcome. ）
Measured: at 90±7 days after onset
Cognition（MoCA） at 90±7 days after onset
Cognition is based on Montreal Cognitive Assessment（MoCA）. （The minimum and maximum values of MoCA is 0 and 30,respectively, higher scores mean a better outcome.）
Measured: at 90±7 days after onset
adverse events(AEs) and serious adverse events（SAEs) through 14 days
Any complications associated with sodium aescinate treatment (e.g. allergy, gastrointestinal complications, bleedings, thrombotic, or infectious complications) were defined as adverse events (AEs). SAEs are defined as any untoward medical occurrence or effect that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity. SAEs and safety endpoints are reported in line with expedited reporting regulations and then adjudicated by an independent panel.
Measured: up to 14 days
all serious adverse events(SAEs) throughout the study follow-up period up to 3 months
SAEs are defined as any untoward medical occurrence or effect that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema BrainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263167
- Sponsor's protocol ID
- 100999
- Status last verified
- Mar 2022
- First submitted
- 9 Jan 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Edema After intraCerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05263167
- Acronym / sponsor ID
- 100999
- Conditions
- Edema Brain
- Keywords
- edema, intracerebral hemorrhage, sodium aescinate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). The primary outcome is the absolute volume of PHE evaluated based on brain CT image on day 14 after ICH.
Detailed description
The REACH trial is a prospective multicenter double-blind randomized placebo-controlled trial with blinded end-point adjudication. Participants are randomized (1:1) to receive either sodium aescinate or matching placebo (0.9% saline). The primary outcome is the absolute volume of PHE evaluated based on brain CT image on day 14 after ICH. Functional outcome is assessed face to face at 3-month after onset. Meanwhile, central telephone follow-up determines functional outcomes at 3-month after onset. Brain imaging (CT) is performed as part of routine care prior to enrolment. A research CT scan is performed after 24h of symptom onset to assess hematoma expansion; a second research CT scan is performed at 72 hours after onset to assess brain swelling and dynamic change of PHE. The study was approved by the ethics committee of the Beijing Tiantan hospital. The study is conducted according to GCP guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium aescinate group | Experimental | Drug: Sodium AescinateTrial treatment is administered as sodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days. |
| placebo group | Placebo comparator | Drug: PlaceboTrial treatment is administered as 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged between 18-80 years old;
- Spontaneous ICH confirmed by cranial CT;
- Time from onset to randomization within 24 hours;
- Superatentorial ICH;
- Hematoma volume between 10-30 ml (calculated using ABC/2 method);
Key exclusion criteria (18 listed)
- Suspected secondary cause of ICH (e.g. aneurysm, vascular malformation, neoplasia, cerebral venous thrombosis, hemorrhagic transformation of recent ischemic stroke, thrombolysis or endovascular treatment, anticoagulation, et al);
- ICH secondary to trauma；
- Primary intraventricular hemorrhage (IVH);
- Signs of herniation, such as progressive decline in consciousness, decreased or disappearance of pupillary light reflection, bilateral pyramidal tract signs, etc;
- Other serious, advanced or terminal illness such that life expectancy is less than one year (e.g. advanced metastatic cancer);
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 |
|---|---|---|
| Sodium AescinateAlso: Sodium Aescinate for Injectionsodium Aescinate 10mg in 250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days. | Drug | sodium aescinate group |
| PlaceboAlso: 0.9% sodium chloride injection250ml sodium chloride 0.9% infusion bag intravenously once daily for 10 days. | Drug | placebo group |
Primary outcome
Absolute edema volume on day 14 after ICH
Time frame: on day 14 after ICH
Absolute edema volume is based on brain CT image
19 secondary outcomes
Relative edema volume on day 14 after ICH
Time frame: on day 14 after ICH
Absolute edema volume and relative edema volume on 24 ±12 hour and 72±12 hour after ICH symptom onset
Time frame: on 24±12 hour and 72±12 hour after ICH symptom onset
Cytotoxic edema on 72 ±12 hour after ICH symptom onset
Time frame: on 72 ±12 hour after ICH symptom onset
Dynamic changes of serum IL-x levels(ng/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum NF-kB levels(ug/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum TNF levels(ng/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum MMPs levels(ug/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum VEGF levels(pg/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum EPO levels(ng/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Dynamic changes of serum angiopoietin-1 levels(pg/ml) within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Change of neurological dysfunction within 14 days of symptom onset
Time frame: within 14 days of symptom onset
Cognition（MMSE) at 14 days of symptom onset
Time frame: at 14 days of symptom onset
Cognition（MoCA) at 14 days of symptom onset
Time frame: at 14 days of symptom onset
Dependency at 90±7 days after onset
Time frame: at 90±7 days after onset
Quality of life at 90±7 days after onset
Time frame: at 90±7 days after onset
Cognition（MMSE） at 90±7 days after onset
Time frame: at 90±7 days after onset
Cognition（MoCA） at 90±7 days after onset
Time frame: at 90±7 days after onset
adverse events(AEs) and serious adverse events（SAEs) through 14 days
Time frame: up to 14 days
all serious adverse events(SAEs) throughout the study follow-up period up to 3 months
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Ji principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Aescinate in people with Edema Brain, run by Beijing Tiantan Hospital.
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 7 inclusion and 18 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 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hao Feng (13811059362, fenghao57865578@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute edema volume on day 14 after ICH (time frame: on day 14 after ICH). 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 21 Mar 2022.