Chinese Herbal Medicine in Acute INtracerebral Haemorrhage (CHAIN) Trial

NCT ID: NCT05066620

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2025-01-31

Brief Summary

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.

Detailed Description

A multicentre, prospective, randomised, double-blind, placebo-controlled trial to be conducted through hospital network of investigators in China. A total of 1504 patients with ICH will be recruited from approximately 20-30 hospitals. Randomised is via a central internet-based system according to block random grouping method stratified by site, neurological severity NIHSS <15 vs ≥15), and haematoma location (basal ganglia + lobe vs thalamus + cerebellum + brain stem + ventricle) to ensure balance in key prognostic factors. Endpoint assessment will be blinded to treatment allocation. The primary aim of this study is to determine the effectiveness and safety of a Chinese herbal medicine FYTF-919 as compared to placebo on functional recovery according to Utility-weighted modified Rankin scale (UW-mRS) at 90 days after acute ICH. Secondary aims include examining whether the Chinese herbal medicine FYTF-919 leads to positive treatment effect on: 1) Utility-weighted mRS scores at 180 days; 2)Ordinal analysis of 7 levels of mRS at 28 days, 90 days and 180 days; 3) Poor prognosis, defined as mRS 4-6 points at 28 days, 90 days and 180 days; 4) NIHSS score at 7 days and 28 days; 5) Mortality rate at 28 days, 90 days and 180 days; 6) Discharge rate at 28 days; 7) EQ-5D-5L at 28days, 90 days and 180 days; 8) BI at 28 days, 90 days and 180 days; 9) The cerebral edema volume at baseline, 24 hours, 7 days, 14 days or at discharge; 10) The hematoma volume at baseline, 24 hours, 7 days, 14 days or discharge; 11) The incidence of stroke-associated pneumonia (SAP) patients; 12) Clinical pulmonary infection score (CIPS) at the onset of SAP, 3 days, and 7 days, after the occurrence of SAP; 13) Chest imaging (DR/CT), body temperature, white blood cell count, C-reactive protein (CRP), procalcitonin (PCT) blood gas analysis, and sputum culture/airway aspirate culture at the onset of SAP, 3 days, and 7 days after the occurrence of SAP; 14) Antibiotic usage among patients with SAP.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

Chinese herbal medicine FYTF-919: Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Group Type: EXPERIMENTAL

Chinese herbal medicine FYTF-919

Intervention Type: DRUG

Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Control group

Placebo treatment: Oral liquid 33ml TID (or patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Group Type: PLACEBO_COMPARATOR

Chinese herbal medicine FYTF-919

Intervention Type: DRUG

Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Interventions

Chinese herbal medicine FYTF-919

Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml \* Q6H will be given through nasal feeding)

Intervention Type: DRUG

Other Intervention Names

Chinese herbal medicine

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years;

2. Diagnosis of spontaneous ICH, confirmed by brain imaging;

3. Presentation within 48 hours of symptom onset (or last seen well);

4. Meet any of the following criteria: a) NIHSS ≥8, or b) GCS 7-14;

5. Provide written informed consent by patient (or approved surrogate);

Exclusion Criteria

1. ICH secondary to a structural abnormality in the brain (e.g. cerebrovascular malformation, arterial aneurysm, tumour, Moyamoya disease, trauma, or previous ischaemic stroke), or secondary to presumed cerebrovascular amyloidosis, or secondary to reperfusion treatment for ischaemic stroke, or secondary to anticoagulant treatment, or secondary to antiplatelet treatment.

2. Unlikely to potentially benefit from therapy (e.g. advanced dementia) or judged by responsible treating clinician to have a high likelihood of early death irrespective of treatment;

3. Other medical illness that will interfere with outcome assessments and follow-up (e.g. known significant pre-stroke disability [modified Rankin scale {mRS} scores 4-5], advanced cancer and renal failure);

4. Known definite contraindication to the Chinese herbal medicine;

5. Women who are known to be pregnant or lactating;

6. Currently participating in another trial which would interfere with outcome assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The George Institute

OTHER

Sponsor Role: collaborator

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

jianwen guo, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

The George Institute for Global Health, Australia

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Jianwen Guo, MD

Role: CONTACT

jianwen_guo@qq.com

+86-13724899379

Facility Contacts

Jianwen Guo, MD

Role: primary

jianwen_guo@qq.com

+86 13724899379

Lily Song, PhD

Role: backup

lsong@georgeinstitute.org.cn

+86 13916466400

References

Guo J, Chen X, Wu M, Wang D, Zhao Y, Li Q, Tang G, Che F, Xia Z, Liang Z, Shi L, Jiang Q, Chen Y, Liu X, Ren X, Ouyang M, Wang B, You S, Billot L, Wang X, Liu Z, Jing H, Meng W, Tian S, Liu E, Xiang Y, Tang X, Xie T, Cui W, Zheng Y, Cao J, Zhang J, Wen Z, Huang T, Wang L, You C, Pan S, Cai Y, Lu Y, Hankey GJ, Al-Shahi Salman R, Anderson CS, Song L; CHAIN investigators. Traditional Chinese medicine FYTF-919 (Zhongfeng Xingnao oral prescription) for the treatment of acute intracerebral haemorrhage: a multicentre, randomised, placebo-controlled, double-blind, clinical trial. Lancet. 2024 Nov 30;404(10468):2187-2196. doi: 10.1016/S0140-6736(24)02261-X. Epub 2024 Nov 12.

Reference Type: DERIVED

PMID: 39547249 (View on PubMed)

Other Identifiers

2020B1111100009

Identifier Type: -

Identifier Source: org_study_id