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Incidence of Thrombosis After Limb Salvage Surgery in Patients Receiving Rivaroxaban or Standard Treatment

Incidence of Venous Thromboembolism post-revascularization of the lower limb in patients receiving Rivaroxaban in arterial dose versus standard treatment - randomized clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-6mctrm2
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-03-12
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Venous Thrombosis

Interventions

This is a controlled clinical trial, one blinded. A total of 200 patients who meet the eligibility criteria will be randomly allocated to the intervention group (ASA + Rivaroxaban 2.5 mg twice a day)

Sponsors

Hospital das Clínicas da Universidade Federal de Pernambuco
Lead Sponsor
Hospital das Clínicas da Universidade Federal de Pernambuco
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adult participants, with no age limit; regardless of gender; patients with threatening ischemia of the limb and with a proposal for limb revascularization, either by angioplasty or by bypass surgery, at the Vascular Surgery Service of the Hospital das Clínicas of the Federal University of Pernambuco, a branch of the Brazilian Hospital Services Company (HC/EBSERH – UFPE) and sign the free and informed consent form (TCLE)

Exclusion criteria

Exclusion criteria: Patients who present a symptomatic venous thromboembolism (VTE) event during hospitalization will be excluded, they will need full anticoagulation and no longer prophylactic; patients who have any contraindications to the use of Rivaroxaban; do not return for the 30th post-operative day consultation

Design outcomes

Primary

MeasureTime frame
To evaluate the incidence of Deep Vein Thrombosis in the post-hospital discharge segment of patients undergoing limb salvage surgery using standard treatment versus Rivaroxaban in an arterial dose plus acetylsalicylic acid.

Secondary

MeasureTime frame
To determine the incidence of bleeding with the use of Rivaroxaban in an arterial dose plus acetylsalicylic acid, in the postoperative period of limb salvage surgery.

Countries

Brazil

Contacts

Public ContactGabriela Buril

Hospital das Clínicas da Universidade Federal de Pernambuco

gabriela.buril@ufpe.br+55(81)21263805

Outcome results

None listed

Source: REBEC (via WHO ICTRP)