NCT04454723

Brief Summary

The purpose of this pilot research study is to evaluate the effectiveness of blood and platelet transfusions in improving symptoms and quality of life of patients enrolled in hospice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

June 12, 2020

Last Update Submit

March 4, 2024

Conditions

Hematologic Malignancy

Keywords

hospice

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with improved quality of life after receiving transfusions.

    Improved quality of life (QOL) and palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.

    6 months

  • Proportion of subjects with improved palliative efficacy after receiving transfusions.

    Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires.

    6 months

Study Arms (1)

Tranfusions and blood collection

EXPERIMENTAL

Patients enrolled will receive one unit each of blood and/or platelet transfusions once a week based on trigger symptoms of anemia and/or thrombocytopenia, along with blood sample collections. Data on patient demographics, disease, and length of hospice stay will also be collected.

Procedure: Blood and/or platelet transfusionProcedure: Complete blood count (CBC) collection

Interventions

Blood and/or platelet transfusionPROCEDURE

The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia.

Tranfusions and blood collection
Complete blood count (CBC) collectionPROCEDURE

CBC will be collected from patients weekly while on this protocol.

Tranfusions and blood collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients \>= 18 years with a primary diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), "high risk" Non-Hodgkin's Lymphoma (NHL), multiple myeloma (MM) and Myelodysplastic Syndrome (MDS) with a life expectancy of \< 6 months who are transfusion dependent. Criteria for transfusion dependence is Symptom Questionnaire symptom grade 2 or higher. The Symptom Questionnaire is based on CTCAE (Common Terminology Criteria for Adverse Events) v5.0, with criteria modified for palliative care patients.
  • Patients wanting to enroll in hospice.
  • Availability of peripheral IV access line or patient agrees to have semi-permanent IV line placed.

You may not qualify if:

  • Patients with \> 6-month survival.
  • Patients unwilling to go on hospice.
  • Patients with antibodies to blood or platelets that would preclude ability to give blood/platelets without prolonged blood typing and or need for anti-HLA platelets.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Platelet TransfusionBlood Cell Count

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeuticsCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Jennifer Holter, MD

    University of Oklahoma

    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
SPONSOR

Study Record Dates

First Submitted

June 12, 2020

First Posted

July 1, 2020

Study Start

August 14, 2020

Primary Completion

August 16, 2023

Study Completion

August 17, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)