Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01976442
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 68.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute

Detailed Description

The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of Washed Transfusions in Adult Patients With Acute Myeloid or Lymphoid Leukemia
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Outcome Measures

Primary Outcome Measures

1. Survial Rate at 30 Days [30 days]

   The percentage of patients who were alive at 30 days after transfusion.

2. Survial Rate at 60 Days [60 days]

   The percentage of patients who were alive at 60 days after transfusion.

3. Survial Rate at 100 Days [100 days]

   The percentage of patients who were alive at 100 days after transfusion.

4. Survial Rate at 5 Years [5 years]

   The percentage of patients who were alive at 5 years after transfusion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL)

Exclusion Criteria:

• all other patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Strong Memorial Hospital (University of Rochester Medical Center)	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Neil Blumberg, M.D., University of Rochester Medical Center, School of Medicine and Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

• Blumberg N, Heal JM, Rowe JM. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440]. BMC Blood Disord. 2004 Dec 10;4(1):6.

• Responsible Party: Neil Blumberg, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01976442
• Other Study ID Numbers: URMC RSRB00035034
• First Posted: Nov 5, 2013
• Last Update Posted: Apr 11, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Neil Blumberg, Professor, University of Rochester: Leukemia; Transfusion
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

Participant Flow

Arm/Group Title	Washed	Unwashed
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Period Title: Overall Study
STARTED	69	31
COMPLETED	69	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Washed	Unwashed	Total
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.	Total of all reporting groups
Overall Participants	69	31	100
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	40	30	35
Sex: Female, Male (Count of Participants)
Female	46 66.7%	18 58.1%	64 64%
Male	23 33.3%	13 41.9%	36 36%
Region of Enrollment (participants) [Number]
United States	69 100%	31 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Survial Rate at 30 Days
Description	The percentage of patients who were alive at 30 days after transfusion.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Washed	Unwashed
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Measure Participants	69	31
Number [percentage of participants]	100 144.9%	97 312.9%

2. Primary Outcome

Title	Survial Rate at 60 Days
Description	The percentage of patients who were alive at 60 days after transfusion.
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Washed	Unwashed
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Measure Participants	69	31
Number [percentage of participants]	97 140.6%	94 303.2%

3. Primary Outcome

Title	Survial Rate at 100 Days
Description	The percentage of patients who were alive at 100 days after transfusion.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Washed	Unwashed
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Measure Participants	69	31
Number [percentage of participants]	96 139.1%	87 280.6%

4. Primary Outcome

Title	Survial Rate at 5 Years
Description	The percentage of patients who were alive at 5 years after transfusion.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Washed	Unwashed
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Measure Participants	69	31
Number [percentage of participants]	55 79.7%	39 125.8%

Adverse Events

Adverse Event Reporting Description	Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Arm/Group Title	Washed		Unwashed
Arm/Group Description	Washed red blood cell transfusions given to all patients with acute myeloid leukemia.		Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
All Cause Mortality
	Washed		Unwashed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Washed		Unwashed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Washed		Unwashed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

This is a cohort study and thus has limits as to confounding and bias. However, it reproduces the results of a previous single center randomized trial.

More Information

Certain Agreements

Principal Investigators are NOT 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.