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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia Aplastic Anemia Bone Marrow Failure Hematopoietic and Lymphoid Cell Neoplasm Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (patient-driven RBCT)

Patients undergo red blood cell transfusions (RBCT) based on their perception and/or the presence of anemia symptoms for up to 6 months.

Group Type EXPERIMENTAL

Red Blood Cell Transfusions (RBCT)

Intervention Type PROCEDURE

Undergo patient-driven RBCT

Interventions

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Red Blood Cell Transfusions (RBCT)

Undergo patient-driven RBCT

Intervention Type PROCEDURE

Other Intervention Names

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Blood Component Transfusion Blood Transfusion Transfusion Transfusion of Blood Products

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No