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

NCT03086252 | Withdrawn DMC

• 3 other identifiers: IRB00090306NCI-2016-01059Winship3145-16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months of study participation

Secondary Outcomes (5)

• Frequency of RBC units transfused

  Up to 6 months of study participation

• Hemoglobin concentration at the time subject requests RBCT

  Up to 6 months of study participation

• Number of RBC units transfused

  Up to 6 months of study participation

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

  Up to 6 months of study participation

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

  Up to 6 months of study participation

Study Arms (1)

Supportive care (patient-driven RBCT)

EXPERIMENTAL

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

Procedure: Red Blood Cell Transfusions (RBCT)

Interventions

Red Blood Cell Transfusions (RBCT) PROCEDURE

Undergo patient-driven RBCT

Also known as: Blood Component Transfusion, Blood Transfusion, Transfusion, Transfusion of Blood Products

Supportive care (patient-driven RBCT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Anemia; Anemia, Aplastic; Bone Marrow Failure Disorders; Hematologic Neoplasms; Leukemia; Myelodysplastic Syndromes

Interventions

Erythrocyte Transfusion; Blood Component Transfusion; Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ana Antun, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 22, 2017
• Study Start: July 24, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

US (1)