Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia

• Sponsor: Fred Hutchinson Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03195010
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This pilot clinical trial compares the safety of two different platelet transfusion "thresholds" among patients with blood cancer or treatment-induced thrombocytopenia whose condition requires anticoagulant medication (blood thinners) for blood clots. Giving relatively fewer platelet transfusions may reduce the side effects of frequent platelet transfusions without leading to undue bleeding.

Condition or Disease	Intervention/Treatment	Phase
Acute Biphenotypic Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; B-Cell Non-Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematologic and Lymphocytic Disorder; Hematopoietic Cell Transplantation Recipient; Myelodysplastic Syndrome; Primary Myelofibrosis; Secondary Myelofibrosis; T-Cell Non-Hodgkin Lymphoma; Thrombocytopenia; Venous Thromboembolism	Biological: Platelet Transfusion; Biological: Platelet Transfusion	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine feasibility of a randomized controlled trial comparing two different platelet transfusion thresholds (50 x 10^{9/L versus [vs] 30 x 10}9/L) in patients with treatment or malignancy-induced thrombocytopenia requiring therapeutic anticoagulation.

SECONDARY OBJECTIVES:

1. Progressive or new venous thromboembolic (VTE).

2. Progressive or new arterial thromboembolism (ATE).

3. Hemorrhagic events (World Health Organization [WHO] grade 2 or greater).

4. A composite of I, II and III.

5. Major bleeds (WHO grade 3 or 4).

6. Number of platelet transfusions per patient during the study period.

7. Platelet transfusion related complications (including transfusion reactions, alloimmunization and volume overload).

8. Degree to which platelet target thresholds are achieved.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I (Lower dose): 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.

GROUP II (Higher dose): 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.

After completion of study, patients are followed up at 30 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
• Actual Study Start Date: Jun 9, 2017
• Actual Primary Completion Date: Dec 21, 2018
• Actual Study Completion Date: Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Platelet Transfusion; Undergo lower dose platelet transfusion; Other Names: Blood Platelet Transfusion
Experimental: 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.	Biological: Platelet Transfusion; Undergo higher dose platelet transfusion; Other Names: Blood Platelet Transfusion

Outcome Measures

Primary Outcome Measures

1. Number of Eligible Patients Approached for the Study [Up to 1 year]

2. Number of Patients Approached for But Refusing Consent [Up to 1 year]

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

3. Number of Patients Consenting to Enrollment [Up to 1 year]

4. Number of Patients Eligible [Up to 1 year]

5. Number of Patients Screened and Deemed Ineligible [Up to 1 year]

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

6. Number of Patients Successfully Following Protocol [Up to 1 year]

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

Secondary Outcome Measures

1. Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater) [Up to 1 year]

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

2. Major Bleeds (World Health Organization Grade 3 or 4) [Up to 1 year]

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

3. Number of Platelet Transfusions Per Patient During the Study Period [Up to 1 year]

4. Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given) [Up to 1 year]

   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.

5. Platelet Transfusion Related Complications [Up to 1 year]

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

6. Progressive or New Arterial Thromboembolism [Up to 1 year]

   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).

7. Progressive or New Venous Thromboembolic [Up to 1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Fred Hutchinson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: David Garcia, Fred Hutch/University of Washington Cancer Consortium

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 27, 2017

More Information

Publications

None provided.

• Responsible Party: Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT03195010
• Other Study ID Numbers: 9799; NCI-2017-00864; 9799; P30CA015704
• First Posted: Jun 22, 2017
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, B-Cell; Lymphoma, T-Cell; Leukemia, Biphenotypic, Acute; Thromboembolism; Venous Thromboembolism; Myelodysplastic Syndromes; Thrombocytopenia; Primary Myelofibrosis; Hematologic Diseases

Study Results

Participant Flow

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	2	2
COMPLETED	2	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	2	2	4
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42	35	39
Sex: Female, Male (Count of Participants)
Female	1 50%	1 50%	2 50%
Male	1 50%	1 50%	2 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 100%	2 100%	4 100%
Region of Enrollment (participants) [Number]
United States	2 100%	2 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Number of Eligible Patients Approached for the Study
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Approached Patients
Arm/Group Description	Eligible patients approached for participation
Measure Participants	4
Count of Participants [Participants]	4 200%

2. Primary Outcome

Title	Number of Patients Approached for But Refusing Consent
Description	Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Approached Patients
Arm/Group Description	Eligible patients approached for participation
Measure Participants	4
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Number of Patients Consenting to Enrollment
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Approached Patients
Arm/Group Description	Eligible patients approached for participation
Measure Participants	4
Count of Participants [Participants]	4 200%

4. Primary Outcome

Title	Number of Patients Eligible
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screened Patients
Arm/Group Description	Patients screened for eligibility
Measure Participants	7
Count of Participants [Participants]	4 200%

5. Primary Outcome

Title	Number of Patients Screened and Deemed Ineligible
Description	Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screened Patients
Arm/Group Description	Patients screened for eligibility
Measure Participants	7
Count of Participants [Participants]	3 150%

6. Primary Outcome

Title	Number of Patients Successfully Following Protocol
Description	Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Count of Participants [Participants]	2 100%	2 100%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Count of Participants [Participants]	0 0%	0 0%

8. Secondary Outcome

Title	Major Bleeds (World Health Organization Grade 3 or 4)
Description	Will evaluate the major bleeds (World Health Organization grade 3 or 4).
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

Title	Number of Platelet Transfusions Per Patient During the Study Period
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Mean (Full Range) [platelet transfusions]	2	9

10. Secondary Outcome

Title	Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)
Description	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.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Number [percentage of study days]	0	3.8

11. Secondary Outcome

Title	Platelet Transfusion Related Complications
Description	Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Number [Platelet transfusion complication]	0	2

12. Secondary Outcome

Title	Progressive or New Arterial Thromboembolism
Description	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).
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Count of Participants [Participants]	0 0%	0 0%

13. Secondary Outcome

Title	Progressive or New Venous Thromboembolic
Description	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.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Lower Dose Platelet Transfusion)	Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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	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
Measure Participants	2	2
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	On study time (varied between subjects)
Arm/Group Title	Group I (Lower Dose Platelet Transfusion)		Group II (Higher Dose Platelet Transfusion)
Arm/Group Description	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		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
All Cause Mortality
	Group I (Lower Dose Platelet Transfusion)		Group II (Higher Dose Platelet Transfusion)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Serious Adverse Events
	Group I (Lower Dose Platelet Transfusion)		Group II (Higher Dose Platelet Transfusion)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Group I (Lower Dose Platelet Transfusion)		Group II (Higher Dose Platelet Transfusion)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		2/2 (100%)
Gastrointestinal disorders
mucositis	1/2 (50%)	1	2/2 (100%)	2
transaminitis	0/2 (0%)	0	1/2 (50%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.