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NCT Number: NCT05766865

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

Emergency neurosurgery

Procedure

Surgical evacuation for intracerebral hemorrhage

Conservative treatment

Procedure

Standard treatment for intracerebral hemorrhage

Primary outcomes

  1. Total mortality

    Time frame: From admission to 6 months after the occurrence primary hemorrhage

Secondary outcomes

  1. Postoperative intracranial bleeding

    Time frame: Within one week after surgery

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Chao Yang Hospital
  • Beijing Pinggu District Hospital
  • Beijing Shuyi Hospital
  • Guangzhou Red Cross Hospital

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2023
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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