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

Primary Purpose

Anemia, Aplastic Anemia, Bone Marrow Failure

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Red Blood Cell Transfusions (RBCT)

About this trial

This is an interventional supportive care trial for Anemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emory University/Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (patient-driven RBCT)

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.

Frequency, duration, and severity of AEs and severe adverse events will be determined. The proportion of subjects with serious side effects will be calculated with 95% confidence interval. Descriptive statistics will be used to characterize subjects enrolled on the trial: age, sex, race and diagnosis.

Secondary Outcome Measures

Frequency of RBC units transfused

The frequency of RBC units transfused will be compared between study period and prior to enrollment for the same patient (e.g. each patient will serve his/her own control) by Wilcoxon's sign rank test.

Hemoglobin concentration at the time subject requests RBCT

Hemoglobin concentration (Hgb) will be measured in g/dL.

Number of RBC units transfused

The number of RBC units transfused will be compared between study period and prior to enrollment for the same patient (e.g. each patient will serve his/her own control) by Wilcoxon's sign rank test.

QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time hemoglobin is 8 +/- 0.5 g/dL

Will be compared to QoL scores at the time subjects request RBCT by paired t-test and/or Wilcoxon sign rank test.

QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time subjects request RBCT

Will be compared to QoL scores at the time hgb is 8 +/- 0.5 g/dL by paired t-test and/or Wilcoxon sign rank test.

Full Information

NCT ID

NCT03086252

First Posted

March 17, 2017

Last Updated

July 25, 2018

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT03086252

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Slow accrual

Study Start Date

July 24, 2017 (Actual)

Primary Completion Date

May 31, 2018 (Actual)

Study Completion Date

May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (patient-driven RBCT)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Red Blood Cell Transfusions (RBCT)

Other Intervention Name(s)

Blood Component Transfusion, Blood Transfusion, Transfusion, Transfusion of Blood Products

Intervention Description

Undergo patient-driven RBCT

Primary Outcome Measure Information:

Title

Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.

Description

Time Frame