The effect of rivaroxaban on the prevention of deep vein thrombosis in patients with nephrotic syndrome
Evaluation of the effect of rivaroxaban in the prevention of deep renal vein thrombosis in patients with nephrotic syndrome
Design
In this study, 20 patients who are new cases of nephrotic syndrome are to be selected, which patients are divided into two groups of 10 non-selectively.
This subject is designed as a double side open label randomized controlled trial
Settings and conduct
Patients are selected from Namazi and Faghihi hospitals and Motahhari clinic in Shiraz.The study is ambiguous and has no blinding
Participants/Inclusion and exclusion criteria
1.Newly diagnosed nephrotic syndrome (albumin less than 2.5 in a patient with MGN and albumin less than 2 in other cases of nephrotic syndrome)
2. The patient is between 18 and 60 years old
3. Absence of coagulation disorders
4. No active cancer
5. No pregnancy
Do not be treated with aspirin or Plavix
7. Contraindications for possible use of anticoagulants
8. The risk of bleeding of the patient according to HAS-BLED criteria is low to medium risk
9. GFR greater than 60
Intervention groups
In this study, 20 patients who are new cases of nephrotic syndrome are divided into two groups of 10 non-selectively. One group is prevented with rivaroxaban at a dose of 10 mg daily and the other group is prevented with warfarin in the range (2≤INR≤3) (as a control group).
This subject is designed as a double side open randomized controlled trial
Main outcome variables
1.Prevention of deep vein thrombosis of the lower extremities and kidneys with rivaroxaban
2. Thrombosis in the deep veins of the lower extremities and kidneys with rivaroxaban
3. Prevention of deep vein thrombosis of the lower extremities and kidneys with warfarin
4. Thrombosis in the deep veins of the lower extremities and kidneys with warfarin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220422054617N1
Registration date:2022-07-10, 1401/04/19
Registration timing:prospective
Last update:2022-07-10, 1401/04/19
Update count:0
Registration date
2022-07-10, 1401/04/19
Registrant information
Name
Mitra Rasouli asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 872 9856
Email address
arash.nik0000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of rivaroxaban in comparison with warfarin in preventing deep vein thrombosis in patients with nephrotic syndrom
Public title
the effect of rivaroxaban on the prevention of deep vein thrombosis in nephrotic syndrom
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed nephrotic syndrome
Albumin less than 2.5 in a patient with MGN
Albumin less than 2 in other cases of nephrotic syndrome
The age of the patient is between 18 and 60 years
The patient's bleeding risk according to HAS-BLED criteria is low to moderate risk
GFR greater than 60
Exclusion criteria:
coagulation disorders
pregnancy
active cancer
taking aspirin
taking plavix
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study is a random permutation block of four. The sampling method is that A represents the Case group (preventive with rivaroxaban drug) and B represents the control group (preventive with warfarin drug). The number of different situations is six as follows. It is ABBA, BAAB, BBAA, AABB, ABAB, BABA. We assign a number to each of these states. By using the table of random numbers, a list of twenty people (five blocks of four) is produced.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No. 8, the first alley of Farhangian alley, Telemim street
City
behbahan
Province
Khouzestan
Postal code
6361983131
Approval date
2022-04-03, 1401/01/14
Ethics committee reference number
IR.SUMS.MED.REC.1401.010
Health conditions studied
1
Description of health condition studied
Nephrotic syndrom
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Deep vein thrombosis after taking rivaroxaban
Timepoint
At the beginning of the study and once every three months
Method of measurement
Color Doppler ultrasound of the deep veins of the lower extremities and renal arteries
Secondary outcomes
empty
Intervention groups
1
Description
Control group: prophylaxis with warfarinTen patients are treated with warfarin as a control group and at the beginning of the study and once every three months until the albumin is less than 2.5, they undergo color Doppler ultrasound of deep renal veins and lower extremities. The number range is 2 to 3
Category
Prevention
2
Description
Intervention group: under prevention with rivaroxabanAnother 10 patients are prevented with Rivaroxaban 10 mg orally daily and at the beginning and once every three months undergo deep calorie doppler ultrasound. Both groups are prevented with drug and sonography until the albumin is less than 2.5 they take
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi and Shahid Faghihi Hospital and Motahhari Clinic
Full name of responsible person
Maryam Shafiee
Street address
Namazi hospital
City
Shiraz
Province
Fars
Postal code
.......
Phone
+98 916 872 9856
Email
Arash.nik0000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Zand
City
Shiraz
Province
Fars
Postal code
......
Phone
+98 916 872 9856
Fax
Email
Arash.nik0000@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?