Hydroxyurea in the Emergency Room to Lessen Pain in Sickle Cell Crisis

NCT03062501 | Unknown Phase 2

• 1 other identifier: Hemorio 397/16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Anemia, Sickle Cell; Anemia; Sickle-Cell, With Crisis

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events

  as assessed by CTCAE version 4.03

  up to 15 days post last dose

• Number of participants with altered laboratory values related to treatment

  up to 15 days post last dose

Secondary Outcomes (3)

• Time until hospital discharge

  Average, up to 7 days post admission

• Total opioid use (mg of IV morphine)

  From study inclusion until hospital discharge (average, up to 7 days post admission)

• Pain score

  From admission until hospital discharge (average, up to 7 days post admission)

Study Arms (2)

Control (No Hydroxyurea)

NO INTERVENTION

Patients in VOC will be treated according to the center's usual practice and analgesia protocol.

Hydroxyurea

EXPERIMENTAL

Patients in VOC will receive up to three daily doses of 30-40 mg / kg hydroxyurea.

Drug: Hydroxyurea

Interventions

Hydroxyurea DRUG

Patients hospitalized for uncomplicated pain crisis with a pain scale of ≥ 6 during the last 24 hours will receive a dose of 30-40 mg / kg hydroxyurea. This same dose of hydroxyurea will be repeated at 24 h and 48 h after the first dose of hydroxyurea, with dose suspension if the patient is discharged within 48 hours. Patients will also receive the center's usual practice and analgesia protocol.

Hydroxyurea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti: lead

Study Sites (1)

Hemorio

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals

Central Study Contacts

Clarisse Lobo, MD

CONTACT

+ 55 (21) 98133-3606; lobo.clarisse@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 23, 2017
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)