Management of Platelet Transfusion Therapy in Patients Wi... | NCT03195010

NCT03195010

ID	Type	Description	Link
NCI-2017-00864	Registry Identifier	CTRP (Clinical Trial Reporting Program)
9799	Other Identifier	Fred Hutch/University of Washington Cancer Consortium
P30CA015704	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I (lower dose platelet transfusion)	Experimental	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.	Biological: Platelet Transfusion
Group II (higher dose platelet transfusion)	Experimental	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions.	Biological: Platelet Transfusion

Name	Type	Description	Arm Group Labels	Other Names
Platelet Transfusion	Biological	Undergo lower dose platelet transfusion	Group I (lower dose platelet transfusion)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Eligible Patients Approached for the Study		Up to 1 year
Number of Patients Approached for But Refusing Consent	Reasons for ineligibility will be reported qualitatively in order to inform future studies.	Up to 1 year
Number of Patients Consenting to Enrollment		Up to 1 year
Number of Patients Eligible		Up to 1 year
Number of Patients Screened and Deemed Ineligible	Reasons for ineligibility will be reported qualitatively in order to inform future studies.	Up to 1 year
Number of Patients Successfully Following Protocol	Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.	Up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)	Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).	Up to 1 year
Major Bleeds (World Health Organization Grade 3 or 4)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient with non-acute promyelocytic leukemia (APL) acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], biphenotypic leukemia) undergoing curative intent chemotherapy OR any patient undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for a hematologic disorder (including acute leukemia as above, chronic myelogenous leukemia [CML], chronic lymphocytic leukemia [CLL], myelodysplastic syndrome [MDS], primary or secondary myelofibrosis, hypereosinophilic syndromes, plasma cell disorders, B-cell or T-cell lymphoma)
Disease may be measurable or non-measurable
Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose anticoagulation (unfractionated or low-molecular weight heparin or oral anticoagulants) throughout the period of hematopoietic recovery
Anticipated platelet count =< 50 x 10^9/L for >= 5 days within 72 hours of enrollment
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Separate episode of VTE or arterial thrombosis within 3 months of enrollment
Major bleed (WHO grade 3 or 4) within 6 months of enrollment
Active bleeding (grade 2 or higher) at the time of enrollment
History of intracranial bleeding at any time
Disorders of hemostasis including von Willebrand disease, hemophilia, platelet function disorders
Concomitant use of aspirin or non-steroidal anti-inflammatory drugs
Evidence of disseminated intravascular anticoagulation (DIC) as determined by the patient's primary provider
History of alloimmunization (defined as platelet refractoriness with panel reactive antibody [PRA] > 25%) at the time of or prior to enrollment
Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris
Psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or able to become pregnant and unwilling to use two forms of birth control during the study period

Name	Affiliation	Role
David Garcia	Fred Hutch/University of Washington Cancer Consortium	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fred Hutch/University of Washington Cancer Consortium		Seattle	Washington	98109	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 27, 2017

Arm/Group Information

ID	Title	Description
BG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
BG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0002 BG0012 BG0024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00042(23 to 61) BG00135(30 to 40) BG00239(23 to 61)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0002 BG0012 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Eligible Patients Approached for the Study

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Approached Patients	Eligible patients approached for participation

Units	Counts
Participants	OG0004

Title

Denominators

Categories

Title	Measurements
	OG0004

Primary

Number of Patients Approached for But Refusing Consent

Reasons for ineligibility will be reported qualitatively in order to inform future studies.

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Approached Patients	Eligible patients approached for participation

Units	Counts
Participants	OG0004

Title	Denominators	Categories

Primary

Number of Patients Consenting to Enrollment

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Approached Patients	Eligible patients approached for participation

Units	Counts
Participants	OG0004

Title	Denominators	Categories

Primary

Number of Patients Eligible

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Screened Patients	Patients screened for eligibility

Units	Counts
Participants	OG0007

Title	Denominators	Categories

Primary

Number of Patients Screened and Deemed Ineligible

Reasons for ineligibility will be reported qualitatively in order to inform future studies.

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Screened Patients	Patients screened for eligibility

Units	Counts
Participants	OG0007

Title	Denominators	Categories

Primary

Number of Patients Successfully Following Protocol

Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts
Participants

Secondary

Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)

Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts
Participants

Secondary

Major Bleeds (World Health Organization Grade 3 or 4)

Will evaluate the major bleeds (World Health Organization grade 3 or 4).

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts
Participants

Secondary

Number of Platelet Transfusions Per Patient During the Study Period

Posted

Mean

Full Range

platelet transfusions

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts
Participants	OG000

Secondary

Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)

The frequency with which transfusions are given despite a platelet count above the determined threshold will be documented, as will the frequency with which transfusions are not administered within 24 hours after a platelet count below the determined threshold.

Posted

Number

percentage of study days

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts

Secondary

Platelet Transfusion Related Complications

Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.

Posted

Number

Platelet transfusion complication

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts
Participants

Secondary

Progressive or New Arterial Thromboembolism

Will evaluate the progression or new arterial thromboembolism by either documented acute electrocardiographic changes compatible with myocardial injury and/or serum biochemical changes diagnostic of myocardial infarction, or documented imaging (computed tomography or magnetic resonance imaging) changes compatible with infarct due to embolism in the presence of a new neurological deficit, or imaging demonstrated intraluminal filling defects in an arterial distribution accompanied by symptoms of acute ischemia (acute onset pain, pallor, loss of pulses or other end-organ damage).

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Secondary

Progressive or New Venous Thromboembolic

Will evaluate the progressive or new venous thromboembolic. Will require imaging confirmation, defined as intraluminal filling defect(s) on contrast-enhanced computed tomography or incompressible venous segment(s) on ultrasonography.

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion
OG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group I (Lower Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo lower dose platelet transfusion	0	2	0	2	1	2
EG001	Group II (Higher Dose Platelet Transfusion)	Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10^9/L for up to 30 days or until the platelet count spontaneously recovers to > 50 x 10^9 for 3 consecutive days in the absence of transfusions. Platelet Transfusion: Undergo higher dose platelet transfusion	0	2	0	2	2	2

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D007951	Leukemia, Myeloid
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D015448	Leukemia, B-Cell
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D001791	Blood Platelet Disorders
D000095542	Cytopenia
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
mucositis	Gastrointestinal disorders		Non-systematic Assessment	Related to chemotherapy	EG0001 events1 affected2 at risk EG0012 events2 affected2 at risk
transaminitis	Gastrointestinal disorders		Non-systematic Assessment		EG0000 events0 affected2 at risk EG0011 events1 affected2 at risk

ID	Term
D015456	Leukemia, Biphenotypic, Acute
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D015470	Leukemia, Myeloid, Acute
D016393	Lymphoma, B-Cell
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D006402	Hematologic Diseases
D009190	Myelodysplastic Syndromes
D055728	Primary Myelofibrosis
D016399	Lymphoma, T-Cell
D013921	Thrombocytopenia
D054556	Venous Thromboembolism

ID	Term
D016913	Blood Component Transfusion
D001803	Blood Transfusion
D001691	Biological Therapy
D013812	Therapeutics