RECRUITING

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

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Conditions

Severe MalariaThrombocytopeniaMalariaPlasmodium falciparumZambia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

Official Title

Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]

Quick Facts

Study Start:2024-02-24
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05711485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 59 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age \<5 years
  2. * Platelet count ≤75,000/uL
  3. * Hemoglobin \>5 and ≤9 g/dL
  4. * P. falciparum parasitemia ≥500 parasites/uL
  5. * Diagnosis of severe malaria meeting World Health Organization (WHO) criteria
  6. * Ability and willingness of the legal guardian to comply with study protocol for the duration of the study
  7. * Residence within health clinic catchment area
  8. * Signed informed consent obtained from the parent or legal guardian of the participant
  1. * Residence in foster care or children otherwise under government supervision
  2. * Residence outside the hospital catchment area, or plan to leave the area
  3. * Presence of any other condition or abnormality which, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data
  4. * Any contraindication to whole blood transfusion

Contacts and Locations

Study Contact

Matthew M Ippolito, MD PhD
CONTACT
443-287-4809
mippolito@jhu.edu

Principal Investigator

Matthew M Ippolito, MD, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
United States

Collaborators and Investigators

Sponsor: Johns Hopkins Bloomberg School of Public Health

  • Matthew M Ippolito, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-24
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-02-24
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • Malaria
  • Plasmodium falciparum
  • Zambia

Additional Relevant MeSH Terms

  • Severe Malaria
  • Thrombocytopenia