Efficacy of Direct Oral Anticoagulants as a Prophylactic Anticoagulation of Catheter Induced Thrombosis
Primary Purpose
Anticoagulants; Increased
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
catheter induced thromboprophylaxis
Sponsored by
About this trial
This is an interventional prevention trial for Anticoagulants; Increased
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo without anticoagulation
Low Dose Direct Oral Anticoagulation
Arm Description
Without any anticoagulation
Apixaban 2.5 mg twice Rivaroxaban 10 mg plus placebo
Outcomes
Primary Outcome Measures
thromboprophylaxis of catheter induced thrombosis
Prevention of thrombosis
Secondary Outcome Measures
Duplex ultrasonography
duplex ultrasonography of central venous system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05705076
Brief Title
Efficacy of Direct Oral Anticoagulants as a Prophylactic Anticoagulation of Catheter Induced Thrombosis
Official Title
Efficacy of Direct Oral Anticoagulants as a Prophylactic Anticoagulation of Catheter Induced Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 24, 2023 (Anticipated)
Primary Completion Date
March 25, 2024 (Anticipated)
Study Completion Date
June 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulants; Increased
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo without anticoagulation
Arm Type
Placebo Comparator
Arm Description
Without any anticoagulation
Arm Title
Low Dose Direct Oral Anticoagulation
Arm Type
Active Comparator
Arm Description
Apixaban 2.5 mg twice Rivaroxaban 10 mg plus placebo
Intervention Type
Drug
Intervention Name(s)
catheter induced thromboprophylaxis
Intervention Description
Direct oral anticoagulation for catheter induced thromboprophylaxis
Primary Outcome Measure Information:
Title
thromboprophylaxis of catheter induced thrombosis
Description
Prevention of thrombosis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duplex ultrasonography
Description
duplex ultrasonography of central venous system
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nshaat Elsaadany
Phone
01011868166
Email
nshaatelsaadany@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Direct Oral Anticoagulants as a Prophylactic Anticoagulation of Catheter Induced Thrombosis
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