Skip to content

A Multicenter Randomized Controlled Trial on Early Anticoagulation Safety and Efficacy after Spontaneous IntraCerebral Hemorrhage Surgery

A Multicenter Randomized Controlled Trial on Early Anticoagulation Safety and Efficacy after Spontaneous IntraCerebral Hemorrhage Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122067
Enrollment
Unknown
Registered
2026-04-08
Start date
2026-04-08
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous cerebral hemorrhage

Interventions

Experimental group:Preventive anticoagulation therapy should be initiated within 24-48 hours after the surgery: subcutaneous injection of low molecular weight heparin (4100 IU per dose), once a day (q
Control group:Conventional preventive chemical anticoagulation is not carried out.

Sponsors

Chengdu Medical College Clinical Medical College · First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 80 years old; 2. Diagnosed with spontaneous intracerebral hemorrhage through imaging examination; 3. The patient's GCS score was >= 4 at 24 - 48 hours after surgery, and the vital signs were stable during this period; 4. Met the consistent surgical indications as per the ESO/EANS 2025 guidelines and underwent the surgery: A: Supratentorial lobar ICH (GCS 5 - 14 points), onset 15 mL or progressive neurological deterioration, and/or brainstem compression, and/or obstructive hydrocephalus. Completed posterior cranial fossa hematoma evacuation surgery, and could be combined with external ventricular drainage; 5. Complete head CT examination 6 hours after surgery. Recheck head CT at 24 + 6 hours (before medication), and if there is no recurrent hemorrhage or the increase in the bleeding focus is less than 33% or 5 mL of the previous CT volume, it is considered a stable lesion; 6. Complete duplex Doppler ultrasound of the lower extremities veins within 24 - 48 hours after surgery, and no baseline DVT was found; 7. The patient or the family member signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with active intracranial hemorrhage as indicated by a CT scan within 24 hours after surgery; 2. Patients with previous VTE events; 3. Patients with severe coagulation dysfunction: 1). Genetic diseases: hemophilia, von Willebrand disease, hereditary coagulation factor deficiency (such as hereditary factor VIII deficiency); hereditary fibrinogen deficiency; hereditary thrombocytopenia, hereditary giant platelet syndrome; 2). Acquired diseases: severe liver (Child-Pugh grade C) and kidney (serum creatinine > 451 µmol/L) dysfunction; disseminated intravascular coagulation (DIC); hematological malignancies: acute leukemia, lymphoma, multiple myeloma; autoimmune diseases: systemic lupus erythematosus, idiopathic thrombocytopenic purpura, allergic purpura, autoimmune hemolytic anemia; 4. Platelet count lower than 100×10^9/L or coagulation dysfunction; 5. Death or unplanned secondary surgery within 24-48 hours after surgery; 6. Patients who have received long-term therapeutic anticoagulation before admission and are assessed to need to resume therapeutic anticoagulation or undergo therapeutic bridging within 7 days after surgery; 7. Patients with active bleeding from activities such as bronchial dilation, hemorrhoids, esophageal and gastric fundus varices; 8. Patients with contraindications or intolerance to anticoagulant drugs; 9. Patients with poor compliance and unable to complete the study requirements; 10. Patients who cannot be weaned off the ventilator within 6 hours after surgery.

Design outcomes

Primary

MeasureTime frame
VTE composite events within 7 days;Any intracranial hemorrhage occurs;Ninety days after discharge;90-day modified Rankin Scale (mRS) score;

Secondary

MeasureTime frame
ISTH (International Society for Thrombosis and Hemostasis) major bleeding and any bleeding events;All-cause deaths within 90 days;

Countries

China

Contacts

Public ContactXun Xia

Chengdu Medical College Clinical Medical College · First Affiliated Hospital

xiaxuns@126.com+86 28 8301 6042

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026