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. 2023 Jan 26;2023(1):CD012144. doi: 10.1002/14651858.CD012144.pub3

NCT04820972.

Study name Early‐start antiplatelet treatment after neurosurgery in patients with spontaneous intracerebral haemorrhage
Methods Design: randomised controlled PROBE parallel group trial
Setting: multicentre in China
Dates: 1 May 2021 to May 2023
Participants Sample size: 250 participants
Diagnosis: post‐operative ICH
Inclusion criteria
  • 18‐70 years old

  • Nontraumatic spontaneous ICH

  • Postoperative patients with high risk of major adverse cardiac/cerebrovascular and peripheral vessel events (MACCPE):

    • previous history of cerebral infarction or TIA

    • previous history of coronary heart disease or myocardial infarction

    • use ASCVD Risk Estimator Plus (http://tools.acc.org/ASCVD‐Risk‐Estimator‐Plus/#!/calculate/estimate/) to assess the risk of ischaemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction, 10 years risk > 10% is defined as a high risk of cardiovascular ischaemic events

    • The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities. Score > 2 is defined as a high risk of venous thrombosis

  • Patients who received neurosurgical procedures to remove the haematoma, including craniotomy, endoscopic haematoma removal and haematoma aspiration

  • Patients who signed informed consent

  • No history of allergy to salicylic acid preparation

  • Patients who complete the preintervention assessment and meet these criteria:

    • postoperative head CT showed no new infarction or haemorrhage

    • postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis

    • postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischaemia or myocardial infarction


Exclusion criteria
  • There are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc) or tumours in the area of bleeding or the bleeding is suspected to be related to these lesions

  • Ischaemic stroke with haemorrhagic conversion

  • Secondary bleeding due to venous embolism

  • A malignant tumour and expected to have a survival of no more than 3 months

  • Taking antithrombotic agents (vitamin K antagonists (warfarin,) new anticoagulants (dabigatran or rivaroxaban)) in addition to antiplatelet agents

  • Previous history of thrombocytopaenia or coagulation disorders

  • Previous history of AF

Interventions Intervention: aspirin 100 mg once daily antiplatelet therapy starting from the third day after surgery
Comparator: 'traditional'
Outcomes Primary outcomes
  • Intracranial haemorrhage

  • Major adverse cardiac/cerebrovascular and peripheral vessel events


Secondary outcomes: none specified
Duration of follow‐up: 90 days
Starting date 1 May 2021
Contact information JUN WU, MD wujunslf@126.com
Shuo Wang, MD captain9858@126.com
Notes Declarations of interest: not specified in trials register
Sources of funding: not specified in trials register