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
|Condition or disease||Intervention/treatment|
|Anemia, Sickle Cell Sickling Disorder Due to Hemoglobin S||Other: Rapid manual partial exchange transfusion Other: Simple Transfusion|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|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|
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.
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.
- 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
- 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
- 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
- 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
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
|United States, Tennessee|
|Chidlren's Hospital at Erlanger|
|Chattanooga, Tennessee, United States, 37403|
|Principal Investigator:||Jennifer Keates, MD||Children's Hospital at Erlanger|