Trial Outcomes & Findings for Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia (NCT NCT01976442)

NCT ID: NCT01976442

Last Updated: 2017-04-11

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2017-04-11

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Washed n=69 Participants Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Unwashed n=31 Participants Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.	Total n=100 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	30 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	18 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	13 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	31 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Washed n=69 Participants Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Unwashed n=31 Participants Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Survial Rate at 30 Days	100 percentage of participants	97 percentage of participants

PRIMARY outcome

Timeframe: 60 days

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

Outcome measures

Measure	Washed n=69 Participants Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Unwashed n=31 Participants Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Survial Rate at 60 Days	97 percentage of participants	94 percentage of participants

PRIMARY outcome

Timeframe: 100 days

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

Outcome measures

Measure	Washed n=69 Participants Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Unwashed n=31 Participants Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Survial Rate at 100 Days	96 percentage of participants	87 percentage of participants

PRIMARY outcome

Timeframe: 5 years

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

Outcome measures

Measure	Washed n=69 Participants Washed red blood cell transfusions given to all patients with acute myeloid leukemia.	Unwashed n=31 Participants Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
Survial Rate at 5 Years	55 percentage of participants	39 percentage of participants

Adverse Events

Washed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unwashed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Neil Blumberg MD

University of Rochester Medical Center

Phone: (585) 275-3189

Email: neil_blumberg@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place