Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Chengdu University of Traditional Chinese Medicine

Conditions:

Oral Antiplatele

Anticoagulant Drugs

Eligibility:

All Genders

18+ years

Brief Summary

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 radiofre...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.
  • Unable to complete follow-up due to mental disorders, mobility limitations, or other reasons, or refusal to sign the informed consent form.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07208695

Start Date

October 1 2025

End Date

June 1 2026

Last Update

October 6 2025

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