-
Study aim
-
Determining the effect of 600 mg per day N-acetylcysteine tablet compared to not receiving the drug on the anticoagulant panel with crossover method in non-transfusion dependent thalassemia patients who underwent splenectomy
-
Design
-
A controlled, crossover groups, single-blind, randomized, phase 3 clinical trial on 20 patients. Simple randomization will be done using an envelope containing sheets with A and B letters.
-
Settings and conduct
-
Patients referring to the Thalassemia Research Center of Bu Ali Hospital who meet the inclusion criteria are divided into two groups of A and B by simple randomization. Group A receive N-acetylcysteine and group B is without medication. After one month, the group A will not receive medication and group B recieves N-acetylcysteine. The only person responsible for conducting the laboratory tests is considered blind. 5 cc of blood samples will be obtained from the patients at the beginning of the study, one month later and at the end of the second month.
-
Participants/Inclusion and exclusion criteria
-
All non-transfusion-dependent β-thalassemia patients over 18 years of age who underwent splenectomy and are treated with aspirin will be included in the study
-
Intervention groups
-
The patients are randomly divided into two groups: A, who take n-acetylcysteine orally at a dose of 10 mg per body weight (one 600 mg tablet per day) for one month, and B (without medication during the first month). Then, group B will receive the n-acetylcysteine in a cross-over manner in the second month, and group A will be without drug. The washout period is one week.
-
Main outcome variables
-
The primary outcome is a reduction of at least 50% in the anticoagulant panel, and the secondary outcomes are a reduction in factor 5 Leiden, protein c and s, antithrombin 3, and lupus anticoagulant.