NCT05907486

The Use of N-acetylcysteine for Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation

The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombotic Disorder

Interventions

Type	Name	Description
DRUG	N-acetyl-cysteine	8g/d (\>=45kg); 200mg/kg.d (\<45kg), intravenously for at least 4 hours, day -9 to day +45
DRUG	Busulfan	3.2mg/kg, day-7 to day -5, intravenously
DRUG	Cytarabine	2g/m2, day -8, intravenously
DRUG	Cyclophosphamide	1.8g/m2, day -4 to day -3, intravenously

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2023-06-18
• Last updated: 2023-06-18