Clinical trial NCT05907486: The Use of N-acetylcysteine for Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation
Official title: The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Thrombotic Disorder
Keywords: Thrombotic disorder
Hematopoietic stem cell transplantation
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 260
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.

Detailed description: The thrombotic events are increasingly recognized complications of hematopoietic cell transplantation (HCT) associated with significant morbidity and mortality, which include transplantation-associated thrombotic microangiopathy (TA-TMA), sinusoidal obstructive syndrome (SOS), deep vein thrombosis (DVT), pulmonary thromboembolism (PTE), catheter-related thrombosis (CRT), superficial vein thrombosis (SVT), etc. There is a complex interplay on balancing the risk for thrombosis and bleeding in these patients, making treatment decisions particularly challenging. Emerging studies revealed that endothelial injury is the common underlying mechanism among different thrombotic disorders. There is increasing data that N-acetyl-cysteine (NAC) may prevent or improve endothelial dysfunction by inhibiting ROS production and preventing endothelial apoptosis. Our previous study showed low dose NAC could decrease the incidence of TA-TMA. In this study, we aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.

Eligibility criteria: Inclusion Criteria:

1. Aged 16-70 years old
2. Diagnosed as myeloid malignancies, and about to undergo allo-HSCT;
3. ECOG: 0-2;
4. Expected survival longer than 1 month

Exclusion Criteria:

1. Allergic to any components of NAC;
2. Severe dysfunction of heart, liver, lung and kidney;
3. Relapse before HSCT;
4. A history of bronchial asthma, bronchospasm or moderate / severe gastrohelcosis.

Primary outcomes:
measure: The incidence of thrombotic disorders
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: The incidence of relapse
timeFrame: 1 year
measure: The incidence of GVHD
timeFrame: 1 year
measure: The incidence of hematopoietic reconstitution
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Yue Han, Professor
role: STUDY_CHAIR
References:
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