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

NCT05705076 | Unknown

• 1 other identifier: R.22.10.1907.R1.R2.R3
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anticoagulants; Increased

Outcome Measures

Primary Outcomes (1)

• thromboprophylaxis of catheter induced thrombosis

  Prevention of thrombosis

  6 months

Secondary Outcomes (1)

• Duplex ultrasonography

  6 months

Study Arms (2)

Placebo without anticoagulation

PLACEBO COMPARATOR

Without any anticoagulation

Drug: catheter induced thromboprophylaxis

Low Dose Direct Oral Anticoagulation

ACTIVE COMPARATOR

Apixaban 2.5 mg twice Rivaroxaban 10 mg plus placebo

Drug: catheter induced thromboprophylaxis

Interventions

catheter induced thromboprophylaxis DRUG

Direct oral anticoagulation for catheter induced thromboprophylaxis

Low Dose Direct Oral Anticoagulation; Placebo without anticoagulation

Eligibility Criteria

• Age: 10 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (1)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

Central Study Contacts

Nshaat Elsaadany

CONTACT

01011868166; nshaatelsaadany@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 30, 2023
• Study Start: January 24, 2023
• Primary Completion: March 25, 2024
• Study Completion: June 25, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01