Protocol for the Administration of Hydroxyurea During Painful Vaso-occlusive Crisis in Sickle Cell Anemia

Study point of contact

Clarisse Lobo, MD
+ 55 (21) 98133-3606
[email protected]

Locations

1 Brazil site

Age

18 to 60 Years

Genotypes

HbSS

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

This study will investigate the safety, tolerability and potential for the use of up to three
daily doses of 30-40 mg/kg HU (daily) upon hospitalization for painful vaso-occlusive crises
.

participation requirements

– Confirmed diagnosis of homozygous sickle cell anemia (HbSS).

– Hospitalization due to onset of uncomplicated vaso-occlusive crisis (with pain scale≥6
within the last 24 h), confirmed by clinical evaluation.

– Documented and written informed consent

participation restrictions

– Confirmed or suspected pregnancy.

– Initiation of painful crisis> 72h.

– Blood transfusion during the last 8 weeks.

– Admission to Emergency Room due to pain in the last 4 weeks.

– Neutrophil count <2.5 x 109/L or platelet count <95.0 x 109 / L or Hb <4.5 g / dL - Weight <38 Kg or> 95 Kg.

– Interval longer than 8h since arrival at center.

– Non-consent to participate in the study.

Locations

  • Rio de Janeiro, Brazil, Hemorio [Recruiting]