Efficacy of Direct Oral Anticoagulants as a Prophylactic Anticoagulation of Catheter Induced Thrombosis

Direct Oral Anticoagulants

INTRODUCTION:

DOAC's looks like an attractive alternative to VKA because they offer important advantages beyond their easiness of administration, like less interactions and no need of laboratory monitoring. 1 All oral anticoagulant regimens but not aspirin were associated with a lower risk of recurrent VTE, while only VKAs were associated with a higher risk of major bleeding. 2 There have been significant differences between VKAs and DOACs in the risk of major bleeding by the current study size. Even though the risk of major bleeding with VKAs may be lower in patients already challenged to anticoagulation treatment. 3 Furthermore, when deciding on longer term secondary prevention of VTE, DOACs appeared safer than standard-intensity VKAs, taking clinically relevant bleeding or any bleeding into consideration.4-5 Until now there is no randomized controlled trial assessing the role of oral direct anticoagulant as a prophylaxis for catheter associated venous thromboembolism.

Aim of the work: To evaluate the efficacy of direct oral anticoagulants as a prophylactic anticoagulation in thromboprophylaxis of catheter induced thrombosis.

Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura University, Faculty of Medicine, Mansoura, Egypt .

Type of study: Randomized Controlled Prospective study Study duration: 2 years: 2022-2024 Sample size: It will include all patients presented to our department fulfilling the inclusion criteria.

Study population: The study will be conducted in patients with any permanent catheter inserted intravenous either femoral or jugular either for hemodialysis or replacement therapy .

Inclusion criteria: Any permanent catheter inserted intravenous either femoral or jugular either for hemodialysis, replacement or chemotherapy.

Exclusion criteria: History of central venous occlusion, contraindication of direct oral anticoagulants.

Consent: Patients must sign informed consent about possible complications from the therapy.

Data collection: The demographics, symptoms, and preoperative clinical data will be collected.

History Data: including underlying medical conditions, any previous associated morbidity.

Examination: Venous examinations. Laboratory: Blood picture, Blood sugar level, Kidney functions, Liver functions and Coagulation profile.

Imaging: Duplex US Method of Randomization: Computer-based Therapies group A : Apixaban 2.5 mg twice group B : Rivaroxaban 10 mg plus placebo group C : Placebo without anticoagulation Follow up All patients are followed by duplex ultrasonography to assess the thrombosis at the tip of catheter or around the catheter 10 days postoperative and 1, 3, 6, months then after one year, venography is indicated if the clinical evaluation not matched with sonographic results.

Study Overview

• Status: Not yet recruiting
• Conditions: Anticoagulants; Increased
• Intervention / Treatment: Drug: catheter induced thromboprophylaxis

Detailed Description

INTRODUCTION:

DOAC's looks like an attractive alternative to VKA because they offer important advantages beyond their easiness of administration, like less interactions and no need of laboratory monitoring. 1 All oral anticoagulant regimens but not aspirin were associated with a lower risk of recurrent VTE, while only VKAs were associated with a higher risk of major bleeding. 2 There have been significant differences between VKAs and DOACs in the risk of major bleeding by the current study size. Even though the risk of major bleeding with VKAs may be lower in patients already challenged to anticoagulation treatment. 3 Furthermore, when deciding on longer term secondary prevention of VTE, DOACs appeared safer than standard-intensity VKAs, taking clinically relevant bleeding or any bleeding into consideration.4-5 Until now there is no randomized controlled trial assessing the role of oral direct anticoagulant as a prophylaxis for catheter associated venous thromboembolism.

Aim of the work: To evaluate the efficacy of direct oral anticoagulants as a prophylactic anticoagulation in thromboprophylaxis of catheter induced thrombosis.

Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura University, Faculty of Medicine, Mansoura, Egypt .

Type of study: Randomized Controlled Prospective study Study duration: 2 years: 2022-2024 Sample size: It will include all patients presented to our department fulfilling the inclusion criteria.

Study population: The study will be conducted in patients with any permanent catheter inserted intravenous either femoral or jugular either for hemodialysis or replacement therapy .

Inclusion criteria: Any permanent catheter inserted intravenous either femoral or jugular either for hemodialysis, replacement or chemotherapy.

Exclusion criteria: History of central venous occlusion, contraindication of direct oral anticoagulants.

Consent: Patients must sign informed consent about possible complications from the therapy.

Data collection: The demographics, symptoms, and preoperative clinical data will be collected.

History Data: including underlying medical conditions, any previous associated morbidity.

Examination: Venous examinations. Laboratory: Blood picture, Blood sugar level, Kidney functions, Liver functions and Coagulation profile.

Imaging: Duplex US Method of Randomization: Computer-based Therapies Group A : Apixaban 2.5 mg twice Group B : Rivaroxaban 10 mg plus placebo Group C : Placebo without anticoagulation Follow up All patients are followed by duplex ultrasonography to assess the thrombosis at the tip of catheter or around the catheter 10 days postoperative and 1, 3, 6, months then after one year, venography is indicated if the clinical evaluation not matched with sonographic results.

Statistical analysis

· The data will be analyzed using Statistical Package for the Social Sciences. The numerical outcomes e.g. age is calculated as mean. Gender will be recorded as frequency and percentage. Chi Square test is applied to assess the association of various parameters. The results will be considered statistically significant if the p-value is found to be less than or equal to 0.05.

• Study Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nshaat Elsaadany; Phone Number: 01011868166; Email: nshaatelsaadany@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 95 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any permanent catheter inserted intravenous either femoral or jugular either for hemodialysis, replacement or chemotherapy.

Exclusion Criteria:

• History of central venous occlusion, contraindication of direct oral anticoagulants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo without anticoagulation; Without any anticoagulation	Drug: catheter induced thromboprophylaxis; Direct oral anticoagulation for catheter induced thromboprophylaxis
Active Comparator: Low Dose Direct Oral Anticoagulation; Apixaban 2.5 mg twice Rivaroxaban 10 mg plus placebo	Drug: catheter induced thromboprophylaxis; Direct oral anticoagulation for catheter induced thromboprophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thromboprophylaxis of catheter induced thrombosis	Prevention of thrombosis	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duplex ultrasonography	duplex ultrasonography of central venous system	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 24, 2023
• Primary Completion (Anticipated): March 25, 2024
• Study Completion (Anticipated): June 25, 2024

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: R.22.10.1907.R1.R2.R3

Drug and device information, study documents

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