Intervention and Protection of dl-3-n-Butylphthalide in Acute Cerebral Hemorrhage

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026222

Enrollment

Unknown

Registered

2019-09-27

Start date

2019-10-08

Completion date

Unknown

Last updated

2019-09-30

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

Conditions

Cerebral Hemorrhage

Interventions

intervention:dl-3-n-Butylphthalide

control:simulating agent of dl-3-n-Butylphthalide (except dl-3-n-Butylphthalide, conclude all the other things)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Spontaneous supratentorial cerebral hemorrhage; 2. Aged 18-79 years; 3. Patients within 24 hours to 7 days after ICH onset; 4. Randomized and started treatment with dl-3-n-Butylphthalide within 6 hours after enrollment; 5. The patient or legal representative signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Cerebral hemorrhage is caused by secondary factors such as known tumors, arteriovenous malformations, aneurysms and trauma. 2. Combined with subtentorial cerebral hemorrhage confirmed by CT. 3. The Glasgow coma scale(GCS) 1.3; or using anticoagulant drugs such as direct thrombin inhibitors (such as dabigatran), direct inhibitors of factor Xa (such as rivaroxaban), or low molecular heparin, heparin, etc. 10. Disability caused by previous diseases(mRS>2). 11. Severe heart disease, liver disease, kidney disease (eGFR <30 ml/min) or malignancy, life expectancy <3 months. 12. Known to be allergic to dl-3-n-Butylphthalide. 13. Currently participating in other interventional clinical trials.

Design outcomes

Primary

Measure	Time frame
the rate of adverse events in 90 days;	—

Secondary

Measure	Time frame
edema extension distance;cerebral hernia;recurrent cerebral hemorrhage;Bleeding;platelet count;international normalized ratio;prothrombin time;activated partial thromboplastin time;fibrinogen;D-Dimer;national institute of health stroke scale;Glasgow coma scale;hematoma volume;edema volume;modified Rankin score;Mini-mental State Examination;Mini-mental State Examination;Montreal Cognitive Assessment;	—

Measure

Time frame

edema extension distance;cerebral hernia;recurrent cerebral hemorrhage;Bleeding;platelet count;international normalized ratio;prothrombin time;activated partial thromboplastin time;fibrinogen;D-Dimer;national institute of health stroke scale;Glasgow coma scale;hematoma volume;edema volume;modified Rankin score;Mini-mental State Examination;Mini-mental State Examination;Montreal Cognitive Assessment;

—

Countries

China

Contacts

Public ContactZhao Xingquan

Beijing Tiantan Hospital, Capital Medical University

zxq@vip.163.com+86 13501031486

Outcome results

None listed

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