Effect of Oral Antiplatelet or Anticoagulant Drugs on Postoperative Bleeding Risk and Venous Closure Rate in Patients With Lower Extremity Varicose Veins After Radiofrequency Ablation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChengdu University of Traditional Chinese Medicine

About this trial

This observational study aims to assess the effect of oral antiplatelet or anticoagulant drugs on key postoperative outcomes in patients with lower extremity varicose veins who have undergone radiofrequency ablation. Its main objectives are to determine the impact of these medications on postoperative 30-day bleeding risk and postoperative 3-month venous closure rate in this patient population. Researchers will compare three groups-patients receiving oral antiplatelet drugs, those receiving oral anticoagulant drugs, and those not receiving either type of drug-to identify differences in the two key outcomes. Participants will complete baseline data collection (including medical history, medication use, and lower extremity venous assessment) before or shortly after radiofrequency ablation, undergo 30-day postoperative follow-up to evaluate bleeding events (such as minor bleeding or major bleeding requiring medical intervention), receive venous ultrasound at 3 months postoperatively to measure venous closure rate, and report any medication changes or adverse events during the follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older, with a confirmed diagnosis of primary lower extremity varicose veins (CEAP classification C2-C6) based on clinical examination and duplex ultrasound.

Underwent endovenous radiofrequency ablation (RFA) of the great saphenous vein as the primary intervention.

Postoperatively, either: (a) continuously uses standard-dose oral antiplatelet drugs (e.g., aspirin 100mg/day, clopidogrel 75mg/day) or oral anticoagulant drugs (e.g., warfarin with INR maintained at 2.0-3.0, direct oral anticoagulants at standard therapeutic doses) as per clinical routine, or (b) does not use any antithrombotic drugs.

Able to understand and comply with the follow-up schedule (including 30-day bleeding assessment and 6-month duplex ultrasound examination) and provide informed consent.

Disqualifiers

Presence of secondary varicose veins caused by deep vein thrombosis, venous malformation, or other vascular disorders.

History of coagulation disorders (e.g., hemophilia, thrombocytopenia with platelet count <100×10⁹/L) or use of other antithrombotic agents (e.g., low-molecular-weight heparin, glycoprotein IIb/IIIa inhibitors) postoperatively.

Major bleeding events (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 3 months prior to RFA.

Severe hepatic insufficiency (Child-Pugh class C), renal insufficiency (eGFR <30 mL/min/1.73m²), or other life-threatening systemic diseases.

Trial population

The study population includes adults aged ≥18 years with confirmed primary lower extremity varicose veins (CEAP classification C2-C6), validated by clinical examination and duplex ultrasound, who have undergone endovenous radiofrequency ablation (RFA) of the great saphenous vein as the primary treatment. Participants are stratified into three groups based on postoperative antithrombotic medication use per routine clinical practice: those taking standard-dose oral antiplatelet drugs, those using standard oral anticoagulants, and a control group without antithrombotic agents. Excluded individuals are patients with secondary varicose veins (e.g., due to deep vein thrombosis or venous malformations), coagulation disorders, postoperative non-oral antithrombotic use, major bleeding within 3 months before RFA, severe hepatic/renal insufficiency, life-threatening systemic diseases, or those unable to complete follow-up or provide informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Antiplatelet or Anticoagulant Drugs

    Drug

    The goal of this observational study is to assess the effect of postoperative continuous use of standard-dose oral antiplatelet (e.g., aspirin, clopidogrel) or anticoagulant drugs (e.g., warfarin, direct oral anticoagulants) on key postoperative outcomes in patients with primary lower extremity varicose veins who have undergone endovenous radiofrequency ablation (RFA) of the great saphenous vein. Unlike studies focusing on preoperative medication adjustment or single-drug cohorts, this study specifically targets routine postoperative medication use without protocol-mandated dose changes, and distinguishes between two major classes of antithrombotic agents while including a non-user control group. The main questions it aims to answer are: 1) Whether postoperative oral antiplatelet/anticoagulant use correlates with increased 30-day bleeding risk (defined by standardized criteria: minor = localized ecchymosis needing no intervention; major = bleeding requiring transfusion or surgical hemo

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

6-month postoperative venous closure rate

Time frame
6 month
2

6-month postoperative venous closure rate

Time frame
6-month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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