Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment

NCT05766865 | Completed

• 1 other identifier: KY2019-096-02
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Spontaneous Intracranial Hemorrhage; Long-term Antiplatelet Treatment; Emergency Surgery; Complications

Outcome Measures

Primary Outcomes (1)

• Total mortality

  From admission to 6 months after the occurrence primary hemorrhage

Secondary Outcomes (1)

• Postoperative intracranial bleeding

  Within one week after surgery

Interventions

Emergency neurosurgery PROCEDURE

Surgical evacuation for intracerebral hemorrhage

Conservative treatment PROCEDURE

Standard treatment for intracerebral hemorrhage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All severe spontaneous intracerebral hemorrhage (SSICH) patients except those not on long-term oral antiplatelet treatment (LOAPT) receiving conservative treatment.

You may qualify if:

• (1) 18-75 years old;
• (2) non-traumatic intracerebral hemorrhage;
• (3) severe intracerebral hemorrhage, which was defined as patients with supratentorial bleeding volume \> 30 ml, infratentorial bleeding volume \> 10 ml, midline shift \> 1 cm, or large intraventricular hematoma;
• (4) Glasgow coma score (GCS) \< 13;
• (5) family members agree to provide an informed written consent.

You may not qualify if:

• (1) patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors, which were associated with hemorrhage;
• (2) hemorrhagic transformation of cerebral infarction;
• (3) hemorrhage caused by venous thrombosis;
• (4) patients with severe coagulation disorder, e.g., hemophilia;
• (5) patients with coagulation dysfunction caused by malignant tumor, hepatic insufficiency, renal dysfunction, thrombocytopenia, coagulation diseases, and so on;
• (6) patients receiving other anticoagulation medications (vitamin K antagonist and new oral anticoagulants);
• (7) patients not on LOAPT who receive conservative treatment;
• (8) the patients who died before or on arriving at the hospital and within a short period (6 h) after admission.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Shuyi Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• Guangzhou Red Cross Hospital: collaborator
• Beijing Pinggu District Hospital: collaborator

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (27)

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MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shuo Wang

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: March 13, 2023
• Study Start: July 10, 2019
• Primary Completion: May 31, 2022
• Study Completion: November 30, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)