Anticoagulation plus batroxobin for acute cerebral venous thrombosis

Randomized Trial of Anticoagulation Plus Batroxobin for Acute Cerebral Venous Thrombosis (ABACVT)

This trial tests whether adding batroxobin to standard anticoagulation helps adults with acute cerebral venous thrombosis.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07352358 on ClinicalTrials.gov

What this trial studies

Seventy-two adults with neuroimaging-confirmed acute cerebral venous thrombosis within 30 days of symptom onset were randomized using a computer-generated, center-stratified sequence. Participants were assigned across three groups with experimental and control arms allocated 1:1 within each group and then pooled for overall comparison. Allocation was concealed with sealed opaque envelopes and the trial was conducted with patients, families, treating clinicians, and outcome assessors blinded to treatment. All participants received standard anticoagulant therapy and the experimental arms additionally received batroxobin.

Who should consider this trial

Good fit: Adults aged 18 or older with imaging-confirmed acute cerebral venous thrombosis whose symptoms began within 30 days and who can provide informed consent.

Not a fit: Patients with active bleeding, high bleeding risk, recent surgery, current use of anticoagulants or platelet inhibitors, or other exclusion conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, combining batroxobin with anticoagulation could improve recovery or reduce complications in patients with acute CVT.

How similar studies have performed: Batroxobin has been studied in other cerebrovascular thrombotic conditions with mixed results, so its benefit specifically for CVT is not yet well established.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥18 years;
2. Neuroimaging confirmed acute CVT;
3. Symptoms onset was within 30 days prior to enrollment;
4. Signed the informed consent form.

Exclusion Criteria:

1. Patients with bleeding (including those with bleeding disorders due to coagulation and vascular disorders, active peptic ulcers, suspected intracranial hemorrhage, thrombocytopenic purpura, hemophilia, during menstruation, during surgery, urinary tract bleeding, hemoptysis, premature delivery, miscarriage, women immediately after delivery and during the puerperium with bleeding from the sexual organs, etc.);
2. Recently operated patients
3. Patients with a potential for bleeding (such as those with visceral tumors, diverticulitis of the digestive tract, colitis, subacute bacterial endocarditis, severe hypertension, and severe diabetes, etc.);
4. Those who are currently taking anticoagulant drugs and platelet function inhibitors (such as aspirin) and those who are using antifibrinolytic agents;
5. Those with a pre-medication fibrinogen concentration lower than 100 mg/dl;
6. Patients with severe liver or kidney dysfunction and other conditions such as papillary muscle rupture, ventricular septal perforation, cardiogenic shock, and multiple organ failure.
7. Those who have a history of allergy to this preparation.

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ran Meng

Conditions: Cerebral Venous Thrombosis