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

Evaluation of Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in the Surgical Treatment of Colorectal Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonic Cancer; Deep Venous Thrombosis
• Intervention / Treatment: Drug: Rivaroxaban 10 MG

Detailed Description

There are already robust studies in the literature demonstrating the efficacy and safety of using Rivaroxaban 10mg once a day in the prevention of deep vein thrombosis of the lower limbs in patients undergoing orthopedic knee and hip surgeries.1,2,3 Although there are already trials demonstrating the safety and efficacy of the use of rivaroxaban in the treatment of DVT and venous thromboembolism in cancer patients, there is a lack in the literature, to date, of studies on the efficacy and safety of prophylaxis with Ribaroxaban for DVT of the lower limbs in the post-operative period. operative of colorectal cancer surgeries, both open surgeries and videolaparoscopic surgeries.4 There are robust studies in the literature, with about 3645 patients undergoing colorectal cancer surgery, reporting a VTE incidence of about 0.85%. .OBJECTIVE To determine the efficacy and safety of chemoprophylaxis for DVT with Rivaroxaban in patients undergoing surgical treatment of colorectal cancer. Primary objective: prevention of DVT and VTE in patients after colorectal surgery. Secondary objective: rates of bleeding and adverse events in patients undergoing anticoagulant use.

METHOD This is a prospective, observational cohort of patients undergoing surgical treatment for colorectal cancer at the Digestive System and Coloproctology Surgery service at Hospital do Servidor Público Estadual de São Paulo. Patients undergoing chemoprophylaxis with enoxaparin and rivaroxaban to prevent lower limb DVT after surgical treatment of colorectal cancer will be included.

In the immediate postoperative period, they will be submitted to chemoprophylaxis with Enoxaparin 40mg subcutaneously 1x/day for 24 hours up to a maximum of 7 days, depending on the release of the diet and the need for a new surgical approach, and at hospital discharge, Rivaroxaban 10mg orally 1x/day will be prescribed until complete 28 days of prophylactic anticoagulation after surgery. Before surgery and after the last dose of chemoprophylaxis, patients will be evaluated with venous USG-Doppler of the lower limbs, in order to detect any possibility of asymptomatic deep vein thrombosis. In addition, 1 week after hospital discharge, patients will be evaluated for symptoms related to the lower limbs in a return visit, as well as any bleeding resulting from the use of drugs for DVT chemoprophylaxis (Table 1).

For the diagnosis of DVT we will use clinical and laboratory data and especially venous Doppler ultrasound. The main ultrasound data used for the diagnosis of DVT are vessel incompressibility and lack of flow in the analyzed vessels.5,6 Venous Doppler US will be performed by an examiner blinded to the treatment received by the patient, with compression measurements in the common femoral veins, superficial in the middle third and popliteal vein. The evaluation of venous recanalization will be through verification of total, partial or absent venous flow. In addition, the presence of venous reflux and its degree will be quantified.

Diagnostic criteria for acute DVT on Doppler: absence or decrease in venous compression; visible thrombus; increase in venous diameter; no increase in venous diameter with Valsalva; valve immobility; loss of respiratory phasicity; absence or decrease in spontaneous venous flow.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rafael de Athayde Soares, PhD; Phone Number: 11999813931; Email: drrafaelsoaresvasc@gmail.com
• Study Contact Backup: Name: Rogério Cury, M.D; Phone Number: 11999813733; Email: rafaelsoon@hotmail.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04028-000
      • Hospital do Servidor Publico Estadual de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: post-operative patients with colonic cancer; Patients will receive Rivaroxaban 10mg/daily for 28 days after surgery. Only one arm.	Drug: Rivaroxaban 10 MG; Patients in post-operative colonic cancer will receive rivaroxaban 10mg/daily for 28 days after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of rivaroxaban	Patients will evaluated with Duplex ultrasound. Duplex ultrasound using b mode and compressibility. All patients will be evaluated. Safety will be evaluated regarding bleeding and no thrombosis afterall.	28 days after surgery

Collaborators and Investigators

• Sponsor: Hospital do Servidor Publico Estadual

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: deep vein thrombosis,; colonic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Embolism and Thrombosis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Thrombosis; Venous Thrombosis; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 34953614.3.0000.5463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No