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Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell

NCT02561312 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2018-07-27

No results posted yet for this study

Summary

Chronic blood transfusions are essential supportive care for sickle cell patients at high risk for morbidity and mortality due to stroke. These patients, however, are at risk for iron overload. In the investigator's comprehensive sickle cell center, the investigators support chronic transfusion with rapid manual partial exchange transfusions (RMPET) using a single access central line port. The investigators do not have a comprehensive adult sickle cell program but upon transition of patients the patients would be provided simple transfusion (ST) in an adult ambulatory infusion setting due to nursing acuity needed for RMPET. The investigators plan to study the institution's participants currently on chronic transfusion support and compare different transfusion modalities to better understand the effects from switching from RMPET to ST. To date, there are no such comparisons within and between sickle cell patients in the literature.

Conditions

  • Anemia, Sickle Cell
  • Sickling Disorder Due to Hemoglobin S

Interventions

OTHER

Rapid manual partial exchange transfusion

The first four participants will receive peripheral red blood cells via rapid manual partial exchange transfusions every month for 6 months. There is a pre-study washout for 3 months then there is a 3 month test period (data collection) before the participant is transferred to ST treatment.

OTHER

Simple Transfusion

The second group of four participants will receive peripheral red blood cells via simple transfusion every month for 6 months. There is a pre-study washout period for 3 months then there is a 3 month test period (data collection) before the participant is transferred to RMPET treatment.

Sponsors & Collaborators

  • Chattanooga-Hamilton County Hospital Authority

    lead OTHER

Principal Investigators

  • Jennifer Keates, MD · Children's Hospital at Erlanger

Eligibility

Min Age
3 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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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 NCT02561312 on ClinicalTrials.gov