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NCT05766865
Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment
trial testing Emergency neurosurgery in Severe Spontaneous Intracranial Hemorrhage in 450 participants. Completed in 30 November 2022.
31 May 2022
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 10 July 2019 |
| Primary completion | 31 May 2022 |
| Estimated completion | 30 November 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Emergency neurosurgery
- Conservative treatment — full drug profile →
Conditions studied
- Severe Spontaneous Intracranial Hemorrhage — all drugs for Severe Spontaneous Intracranial Hemorrhage →
- Long-term Antiplatelet Treatment — all drugs for Long-term Antiplatelet Treatment →
- Emergency Surgery — all drugs for Emergency Surgery →
- Complications — all drugs for Complications →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 18 to 75, any sex, with Severe Spontaneous Intracranial Hemorrhage or Long-term Antiplatelet Treatment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT. Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSIC H patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage. Results: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established. Conclusions: In this study, we will investigate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Surgery for intracerebral hemorrhage: new evidence and changing perspectives.
de Oliveira Manoel AL, Msheik A, Schuind S, Al Rumaihi GIK, et al · · 2025 · PMID 41327234 · DOI 10.1186/s13054-025-05763-3
Verify or expand the search:
- PubMed search for NCT05766865
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Emergency neurosurgery
Trials testing the same drug.
- NCT05975398 — China Research for Severe Spontaneous Intracerebral Hemorrhage（CRISIH） · unknown
Other Beijing Tiantan Hospital trials
Trials by the same sponsor.
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- NCT07520370 — Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor · NA · not yet recruiting
- NCT07526987 — Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis · Phase 3 · not yet recruiting
- NCT07591207 — The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05766865 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 13 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05766865.
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