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Trial Outcomes & Findings for The SOLID Platelet Study (NCT NCT03712618)

NCT ID: NCT03712618

Last Updated: 2025-05-09

Results Overview

The adjusted platelet increment area under the curve (AUC), obtained between 0-hours and 6-hours after start of the platelet transfusion. The AUC (i.e., AUC above the pretransfusion complete blood count (CBC) platelet count, minus the AUC below the pre-transfusion CBC's platelet count) determined by the 0-hour, 2-hour, 4-hour, and 6-hour CBC platelet concentrations, calculated using the trapezoid rule. Adjustment to the measured AUC done for the number of platelets transfused during the two transfusion periods (LONG and SHORT Transfusion durations) in one block.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

0-6 hours post transfusion

Results posted on

2025-05-09

Participant Flow

Participant milestones

Participant milestones
Measure
Group A: LONG Then SHORT Transfusion
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive LONG platelet transfusion (Transfused over 4-HOURS via infusion pump or gravity) with follow up until 6 hours and then SHORT platelet transfusion (Transfused over 60-minutes via infusion pump or gravity) with follow up until 6 hours for a combined total of 12 hours. Subjects may receive up to two further subsequent blocks (one per day) to be administered to a subject in alternating order of SHORT and LONG platelet transfusions, for a maximum number of three blocks per subject.
Group B: SHORT Then LONG Transfusion
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive SHORT platelet transfusion (Transfused over 60-minutes via infusion pump or gravity) with follow up until 6 hours and then LONG platelet transfusion (Transfused over 4-HOURS via infusion pump or gravity) with follow up until 6 hours for a combined total of 12 hours. Subjects may receive up to two further subsequent blocks (one per day) to be administered to a subject in alternating order of LONG and SHORT platelet transfusions, for a maximum number of three blocks per subject.
Block 1, Day 1
STARTED
1
1
Block 1, Day 1
COMPLETED
1
1
Block 1, Day 1
NOT COMPLETED
0
0
Block 2, Day 2
STARTED
1
0
Block 2, Day 2
COMPLETED
1
0
Block 2, Day 2
NOT COMPLETED
0
0
Block 3, Day 3
STARTED
1
0
Block 3, Day 3
COMPLETED
1
0
Block 3, Day 3
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The SOLID Platelet Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Study Participants
n=2 Participants
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive either LONG platelet transfusion (Transfused over 4-HOURS via infusion pump or gravity) or SHORT platelet transfusion (Transfused over 60-minutes via infusion pump or gravity) with follow up until six (6) hours for each transfusion for a combined total of 12 hours then cross over to receive subsequent intervention. Subjects may receive up to two further subsequent blocks (one per day) to be administered to a subject in alternating order, for a maximum number of three blocks per subject.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 0-6 hours post transfusion

Population: Participants who completed at least one block of transfusion in the study

The adjusted platelet increment area under the curve (AUC), obtained between 0-hours and 6-hours after start of the platelet transfusion. The AUC (i.e., AUC above the pretransfusion complete blood count (CBC) platelet count, minus the AUC below the pre-transfusion CBC's platelet count) determined by the 0-hour, 2-hour, 4-hour, and 6-hour CBC platelet concentrations, calculated using the trapezoid rule. Adjustment to the measured AUC done for the number of platelets transfused during the two transfusion periods (LONG and SHORT Transfusion durations) in one block.

Outcome measures

Outcome measures
Measure
LONG Transfusion
n=2 Participants
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive LONG platelet transfusion (Transfused over 4-HOURS via infusion pump).
SHORT Transfusion
n=2 Participants
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive SHORT platelet transfusion (Transfused within 60-minutes via infusion pump or gravity).
Adjusted Platelet Increment Area Under the Curve (AUC)
1173.5 platelets x 10^3 x min/uL
Standard Deviation 669.2
746.9 platelets x 10^3 x min/uL
Standard Deviation 240.0

SECONDARY outcome

Timeframe: One day before the first Transfusion Block until one day after the last Transfusion Block; up to 5 days total

Population: Participants who completed at least one block of transfusion in the study

The efficacy of continuous platelet infusion on bleeding outcomes was assessed by number of participants with bleeding grade 1 or higher, measured during the peri-transfusion period by daily hemostatic assessments using the World Health Organization (WHO) bleeding scale. The WHO Bleeding Scale is a standardized tool used to assess and grade the severity of bleeding from 0-4: Grade 0: No bleeding. Grade 1: Petechiae (small, pinpoint hemorrhages). Grade 2: Mild blood loss. Grade 3: Gross blood loss (visible blood loss). Grade 4: Debilitating blood loss (severe blood loss that causes weakness)

Outcome measures

Outcome measures
Measure
LONG Transfusion
n=2 Participants
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive LONG platelet transfusion (Transfused over 4-HOURS via infusion pump).
SHORT Transfusion
n=2 Participants
Subjects with thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment-related) randomized to receive SHORT platelet transfusion (Transfused within 60-minutes via infusion pump or gravity).
Participants With Bleeding During the Peri-transfusion Period
0 Participants
0 Participants

Adverse Events

LONG Transfusion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SHORT Transfusion

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

Dr. Willy Flegel

National Institutes of Health, Clinical Center (NIH CC)

Phone: +1 301 594 7401

Results disclosure agreements

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