Deep Venous Thrombosis After Intracerebral Hemorrhage
Conditions
Interventions
Intervention Group:Anticoagulant therapy with [enoxaparin 0.4 mL QD] plus optimal medical treatment (including intermittent pneumatic compression therapy) for 7 days
Control Group:optimal medical treatment (including intermittent pneumatic compression therapy) for 7 consecutive days after randomization.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18–80 years old; 2.Supratentorial spontaneous intracerebral hemorrhage (ICH) with an onset time of 48–72 hours; 3.Hematoma volume 9 at the time of randomization; 5.Informed consent obtained from the patient and/or their family members.
Exclusion criteria
Exclusion criteria: 1.Presence of deep vein thrombosis (DVT) signs after intracerebral hemorrhage (ICH) onset, such as dyspnea, shortness of breath, chest pain, syncope, and asymmetric swelling of the lower extremities; 2.Vascular ultrasound indicating lower extremity deep vein thrombosis (DVT) after intracerebral hemorrhage (ICH) onset; 3.Blood tests, electrocardiogram (ECG), computed tomography pulmonary angiography (CTPA), or other examinations indicating pulmonary thrombosis after intracerebral hemorrhage (ICH) onset; 4.Intracerebral hemorrhage (ICH) considered to be caused by other diseases, such as cerebral aneurysm, cerebrovascular malformation, brain tumor, cerebral venous sinus thrombosis, hemorrhagic transformation of ischemic stroke, traumatic brain injury, anticoagulant therapy, and hematological diseases; 5.Presence of definite contraindications to intermittent pneumatic compression (IPC) therapy, such as severe lower extremity skin diseases, severe lower extremity atherosclerotic vascular disease, and obvious lower extremity edema caused by cardiac or renal dysfunction; 6.Definite history of allergy to low-molecular-weight heparin (LMWH); 7.Primary intraventricular hemorrhage (IVH); 8.Clinical symptoms and signs of the patient indicating cerebral herniation, such as progressive decrease in consciousness level, diminished or absent pupillary light reflex, and bilateral pyramidal tract signs; 9.Severe cardiac insufficiency (New York Heart Association [NYHA] Class III or IV); 10.High risk of chronic arrhythmias, such as sick sinus syndrome, second- or third-degree atrioventricular block, and bradycardia-related syncope without pacemaker implantation; 11.Severe hepatic insufficiency: defined as alanine transaminase (ALT) > 2 times the upper limit of normal (ULN) or aspartate transaminase (AST) > 2 times the upper limit of normal (ULN); 12.Severe renal insufficiency: defined as serum creatinine > 1.5 times the upper limit of normal (ULN); 13.History of severe asthma or chronic obstructive pulmonary disease (COPD); 14.History of coagulation disorder or systemic hemorrhage; 15.Leukopenia ( 2 before intracerebral hemorrhage (ICH) onset; 18.Patients with an expected lifespan of < 1 year due to other severe diseases; 19.Inability to understand the study procedures and/or complete follow-up due to mental illness, cognitive impairment, emotional disorder, or other factors; 20.Pregnant or lactating women; 21.Participation in other clinical studies within 3 months or current participation in other clinical studies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) on Day 10 After Randomization or at Discharge; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS score at 72 ± 12 hours after randomization;NIHSS Score on Day 10 After Randomization or at Discharge;Length of Hospital Stay (Days);Direct Medical Costs During Hospitalization (CNY);Modified Rankin Scale (mRS) Score Shift (Shift Analysis) at 90 ± 7 Days After Randomization;Proportion of Patients with Modified Rankin Scale (mRS) Score = 6 mL Or Relative Hematoma Volume Increase Of >= 33%) Within 10 Days After Randomization Or During Hospitalization;Adverse Events (AEs) Within 10 Days After Randomization or During Hospitalization;Serious Adverse Event (SAE) Within 10 Days After Randomization or During Hospitalization; | — |
Countries
China
Contacts
Public ContactLv Hong
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed