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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05907486

Enrollment

260

Registered

2023-06-18

Start date

2023-08-01

Completion date

2025-12-01

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombotic Disorder

Keywords

Thrombotic disorder, Hematopoietic stem cell transplantation

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.

Interventions

DRUGN-acetyl-cysteine

8g/d (\>=45kg); 200mg/kg.d (\<45kg), intravenously for at least 4 hours, day -9 to day +45

DRUGBusulfan

3.2mg/kg, day-7 to day -5, intravenously

DRUGCytarabine

2g/m2, day -8, intravenously

DRUGCyclophosphamide

1.8g/m2, day -4 to day -3, intravenously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of thrombotic disorders	1 year	The incidence of thrombotic disorders (TA-TMA, SOS, DVT, PTE, CRT, SVT) after allogenic hematopoietic stem cell transplantation
Overall survival	1 year	The rate of overall survival after allogenic hematopoietic stem cell transplantation

Secondary

Measure	Time frame	Description
The incidence of relapse	1 year	The incidence of relapse after allogenic hematopoietic stem cell transplantation
The incidence of GVHD	1 year	The incidence of GVHD after allogenic hematopoietic stem cell transplantation
The incidence of hematopoietic reconstitution	1 year	The incidence of hematopoietic reconstitution after allogenic hematopoietic stem cell transplantation

Contacts

Primary ContactYaqiong Tang, Doctor

tangyaqiong@suda.edu.cn18896588075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026