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

NCT ID: NCT07208695

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-06-01

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 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.

Conditions

Oral Antiplatele; Anticoagulant Drugs; Lower Extremity Varicose Veins; Radiofrequency Ablation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Antiplatelet or Anticoagulant Drugs

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chunshui He

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chunshui He, Doctor

Role: CONTACT

Chunshuihe@msn.com

18981885601

References

San Norberto Garcia EM, Merino B, Taylor JH, Vizcaino I, Vaquero C. Low-molecular-weight heparin for prevention of venous thromboembolism after varicose vein surgery in moderate-risk patients: a randomized, controlled trial. Ann Vasc Surg. 2013 Oct;27(7):940-6. doi: 10.1016/j.avsg.2013.03.006.

Reference Type: BACKGROUND

PMID: 23993109 (View on PubMed)

Gonzalez Ochoa AJ, Carrillo J, Manriquez D, Manrique F, Vazquez AN. Reducing hyperpigmentation after sclerotherapy: A randomized clinical trial. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):154-162. doi: 10.1016/j.jvsv.2020.06.019. Epub 2020 Jul 30.

Reference Type: BACKGROUND

PMID: 32739509 (View on PubMed)

Beyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, Sahin K, Bauersachs R; SURPRISE investigators. Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017 Mar;4(3):e105-e113. doi: 10.1016/S2352-3026(17)30014-5. Epub 2017 Feb 16.

Reference Type: BACKGROUND

PMID: 28219692 (View on PubMed)

Other Identifiers

ChengduUTCM 276

Identifier Type: -

Identifier Source: org_study_id