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Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT04712435 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-03-09

No results posted yet for this study

Summary

Sinusoidal obstruction syndrome (SOS) or hepatic veno-occlusive disease (VOD) is a serious complication that occurs, most often occurring in patients undergoing hematopoietic stem cell transplantation (HSCT), especially in its first thirty days. The morbidity and mortality in this syndrome are considerable, since severe SOS is associated with a mortality of more than 90% in the first hundred days of HSCT.

Some risk factors are modifiable, especially those related to transplantation, but when non-alterable factors are present, preventive measures are needed that can reduce the incidence and / or severity of SOS.

Conditions

  • Sinusoidal Obstruction Syndrome (SOS)
  • Hematopoietic Stem Cell Transplant (HSCT)

Interventions

DRUG

N-acetylcysteine

Eligible patients will be randomised to receive N-acetylcysteine versus matching placebo

DRUG

Placebo

Eligible patients will be randomised to receive N-acetylcysteine versus matching placebo

Sponsors & Collaborators

  • Instituto Brasileiro de Controle do Cancer

    lead OTHER

Principal Investigators

  • Jamilla N Cavalcante, MD · IBCC Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712435 on ClinicalTrials.gov