Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer

NCT05303818 | Unknown Phase 4 DMC

• 1 other identifier: 34953614.3.0000.5463
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The chemoprophylaxis of deep vein thrombosis (DVT) with subcutaneous low-molecular-weight heparin (enoxaparin) in the postoperative period of elective surgeries is already well established in the literature and in clinical practice. However, the use of this medication can have a financial impact on the patient and the parenteral presentation itself is associated with pain at the application site, which can make it difficult for patients to adhere.

Conditions

Deep Venous Thrombosis; Colonic Cancer

Keywords

deep vein thrombosis,; colonic cancer

Outcome Measures

Primary Outcomes (1)

• Deep venous thrombosis and embolic pulmonary disease

  Patients will evaluated with Duplex ultrasound. Duplex ultrasound using b mode and compressibility. All patients will be evaluated.

  28 days after surgery

Secondary Outcomes (1)

• Safety of rivaroxaban

  28 days after surgery

Study Arms (1)

post-operative patients with colonic cancer

EXPERIMENTAL

Patients will receive Rivaroxaban 10mg/daily for 28 days after surgery. Only one arm.

Drug: Rivaroxaban 10 MG

Interventions

Rivaroxaban 10 MG DRUG

Patients in post-operative colonic cancer will receive rivaroxaban 10mg/daily for 28 days after surgery

post-operative patients with colonic cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in post-operative surgery for colonic cancer.
• No contraindication for anticoagulation usage.
• Absence of renal or hepatic failure.

You may not qualify if:

• Pregnancy,
• age \< 18 years,
• contraindication to the use of anticoagulants, -failure to complete the informed consent form. -

Sponsors & Collaborators

• Hospital do Servidor Publico Estadual: lead

Study Sites (1)

Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, 04028-000, Brazil

Location

MeSH Terms

Conditions

Venous Thrombosis; Colonic Neoplasms

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Rafael de Athayde Soares, PhD

CONTACT

11999813931; drrafaelsoaresvasc@gmail.com

Rogério Cury, M.D

CONTACT

11999813733; rafaelsoon@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Patients information will be masked.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MsC, M.D - Investigador Principal - médico preceptor do Serviço de Cirurgia Vascular

Model Details: 68 patients will be selected for the study. All patients must complete an informed consent form regarding the objectives and risks involved in this research

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 31, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)