Patient-Driven Transfusion Thresholds in Hematological Disorders: A Pilot Study

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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