Brief Title
Patient-Driven Transfusion Thresholds in Hematological Disorders: A Pilot Study
Official Title
Patient-Driven Transfusion Thresholds in Hematological Disorders: A Pilot Study
Brief Summary
This pilot study evaluates safety of administration of red blood cell transfusions requested
by patients based on their symptoms instead of levels of hemoglobin for the treatment of
chronic anemia in patients with blood disorders.
Detailed Description
PRIMARY OBJECTIVE:
I. To assess feasibility and safety of red blood cell transfusions at the time subjects
requested based on symptomatic anemia.
SECONDARY OBJECTIVES:
I. To define a patient-driven red blood cell transfusion (RBCT) threshold and to compare the
median hemoglobin (hgb) at the time subjects request RBCT to the standard threshold of hgb <
8 g/dL.
II. To compare the number of red blood cell (RBC) units transfused and the frequency of
transfusions at the time subjects request RBCT during the study period to the number of RBC
units received and frequency using the standard threshold hemoglobin < 8 g/dL during a
comparable period prior to enrollment.
III. To compare the quality of life (QoL) scores when subjects request RBCT to the scores
obtained at the time hgb is 8 +/- 0.5 g/dL.
OUTLINE:
Patients undergo RBCT based on their perception and/or the presence of anemia symptoms for up
to 6 months.
After completion of study treatment, patients are followed up for 30 days.
Study Type
Interventional
Primary Outcome
Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.
Secondary Outcome
Frequency of RBC units transfused
Condition
Anemia
Intervention
Red Blood Cell Transfusions (RBCT)
Study Arms / Comparison Groups
Supportive care (patient-driven RBCT)
Description: Patients undergo red blood cell transfusions (RBCT) based on their perception and/or the presence of anemia symptoms for up to 6 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Start Date
July 24, 2017
Completion Date
May 31, 2018
Primary Completion Date
May 31, 2018
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with hematological malignancy or marrow failure syndrome such as but not
limited to: aplastic anemia, myelodysplastic syndrome or leukemia
- Chronic transfusion-dependent anemia with exposure to at least 5 RBCT
- Interested in reducing transfusion exposure
- Willing to sign informed consent
Exclusion Criteria:
- Recent acute bleeding requiring intervention in less than 24 hours
- Hemoglobin levels < 6 g/dL
- Acute leukemia receiving induction chemotherapy
- Any patient with known ischemic heart disease, history of congestive heart failure,
history of stroke, or cardiac arrhythmia for which the patient requires medication or
a medical device
- Oxygen dependent
- Oxygen saturation below 92% on room air
- Receiving erythropoietin stimulating agent
- Thalassemia major or sickle cell disease requiring blood transfusion
- Undergoing major surgery
- Hemolytic anemia
- Coagulopathies including disseminated intravascular coagulation (DIC), receiving
anticoagulant or antiplatelet agents
- Diagnosed with chronic obstructive pulmonary disease (COPD) oxygen dependent
- Pregnancy
- Participation in a therapeutic clinical trial
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ana Antun, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03086252
Organization ID
IRB00090306
Secondary IDs
NCI-2016-01059
Responsible Party
Principal Investigator
Study Sponsor
Emory University
Study Sponsor
Ana Antun, MD, Principal Investigator, Emory University
Verification Date
July 2018