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
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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
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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
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 |