Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer (Ésquilo)
Primary Purpose
Deep Venous Thrombosis, Colonic Cancer
Status
Not yet recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Rivaroxaban 10 MG
Sponsored by
About this trial
This is an interventional prevention trial for Deep Venous Thrombosis focused on measuring deep vein thrombosis,, colonic cancer
Eligibility Criteria
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. -
Sites / Locations
- Hospital do Servidor Público Estadual de São Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
post-operative patients with colonic cancer
Arm Description
Patients will receive Rivaroxaban 10mg/daily for 28 days after surgery. Only one arm.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05303818
First Posted
February 20, 2022
Last Updated
March 21, 2022
Sponsor
Hospital do Servidor Publico Estadual
1. Study Identification
Unique Protocol Identification Number
NCT05303818
Brief Title
Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer
Acronym
Ésquilo
Official Title
Evaluation of Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in the Surgical Treatment of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital do Servidor Publico Estadual
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis, Colonic Cancer
Keywords
deep vein thrombosis,, colonic cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Masking Description
Patients information will be masked.
Allocation
N/A
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
post-operative patients with colonic cancer
Arm Type
Experimental
Arm Description
Patients will receive Rivaroxaban 10mg/daily for 28 days after surgery. Only one arm.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 10 MG
Intervention Description
Patients in post-operative colonic cancer will receive rivaroxaban 10mg/daily for 28 days after surgery
Primary Outcome Measure Information:
Title
Deep venous thrombosis and embolic pulmonary disease
Description
Patients will evaluated with Duplex ultrasound. Duplex ultrasound using b mode and compressibility. All patients will be evaluated.
Time Frame
28 days after surgery
Secondary Outcome Measure Information:
Title
Safety of rivaroxaban
Description
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.
Time Frame
28 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael de Athayde Soares, PhD
Phone
11999813931
Email
drrafaelsoaresvasc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rogério Cury, M.D
Phone
11999813733
Email
rafaelsoon@hotmail.com
Facility Information:
Facility Name
Hospital do Servidor Público Estadual de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04028-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data.
Learn more about this trial
Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer
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