Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05705076 |
Other study ID # |
R.22.10.1907.R1.R2.R3 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 24, 2023 |
Est. completion date |
June 25, 2024 |
Study information
Verified date |
January 2023 |
Source |
Mansoura University |
Contact |
Nshaat Elsaadany |
Phone |
01011868166 |
Email |
nshaatelsaadany[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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
ยท 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.