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Trial record 14 of 28 for:    sickle cell | "Sickle Cell Trait"

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

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ClinicalTrials.gov Identifier: NCT02561312
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Keates, M.D., Chattanooga-Hamilton County Hospital Authority

Brief 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.

Condition or disease Intervention/treatment
Anemia, Sickle Cell Sickling Disorder Due to Hemoglobin S Other: Rapid manual partial exchange transfusion Other: Simple Transfusion

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Comparison of Two Methods of Transfusion for Stroke Prevention in Sickle Cell
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2017


Group/Cohort Intervention/treatment
RMPET
For rapid manual partial exchange transfusion, participants with a weight >50kg, 500 ml of whole blood is removed from the participant via a single lumen central venous line, followed by infusion of 500 ml of saline. A 30 second wait time is utilized for equilibration to occur. A second 500 ml aliquot is removed, and then two units of packed red blood cells (PRBC) are infused. (This is customized for a patient with large red blood cell mass). For participants <50 kg, the individual exchange aliquots are adjusted to 10 ml/kg or normal saline and PRBC.
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.

Simple Transfusion
For simple transfusion, the volume of packed red blood cells (PRBC) to be transfused in the participant is 10-15 cc/kg. No normal saline exchange is required. All blood is transfused through a single lumen central venous line.
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.




Primary Outcome Measures :
  1. Hemoglobin S, baseline hemoglobin/hematocrit, [ Time Frame: Pre Infusion, lab collected monthly for one year thru study completion ]
    Lab parameters pre-infusion for each method of transfusion


Secondary Outcome Measures :
  1. Hemoglobin S, end of transfusion hemoglobin/hematocrit, blood volume, alloantibodies, [ Time Frame: Post Infusion, lab collected monthly for one year thru study completion ]
    Lab parameters post-infusion for each method of transfusion


Other Outcome Measures:
  1. Nursing Time score [ Time Frame: Monthly at end of each transfusion for one year thru study completion ]
    Determine nursing time to administer straight versus manual exchange transfusion

  2. Patient Satisfaction Questionnaire [ Time Frame: At end of 6 month period and at 12 months (after RMPET and ST) ]
    Patient satisfaction questionnaire consisting of 5 Likert scaled questions for preference of RMPET versus ST assessed after six months on either cohort



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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
8 chronically exchanged transfused participants at T.C. Thompson Children's Infusion Clinic with sickle cell disease (Hemoglobin SS or SBeta thalassemia) currently receiving rapid manual partial exchange transfusion.
Criteria

Inclusion Criteria:

  1. Participants between 3 and 25 years of age
  2. Diagnosis of Hemoglobin SS or SBeta thalassemia
  3. On chronic exchange for stroke prevention
  4. Performance status: Lansky play score of 100%, and if over 16 years of age, Karnofsky=100%

Exclusion Criteria:

  1. Participant has experienced more than one stroke and has a modified Rankin Scale of >3.
  2. Diagnosis of Hemoglobin SC disease
  3. Participants on chronic transfusion for priapism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561312


Locations
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United States, Tennessee
Chidlren's Hospital at Erlanger
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Chattanooga-Hamilton County Hospital Authority
Investigators
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Principal Investigator: Jennifer Keates, MD Children's Hospital at Erlanger

Publications:

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Responsible Party: Jennifer Keates, M.D., Pediatric Oncologist / Hematologist, Chattanooga-Hamilton County Hospital Authority
ClinicalTrials.gov Identifier: NCT02561312     History of Changes
Other Study ID Numbers: 15-084
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn