Trial Outcomes & Findings for SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia (NCT NCT03419780)
NCT ID: NCT03419780
Last Updated: 2020-11-04
Results Overview
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
From randomization until discharge from admission for delivery, an average of 2-3 days
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Single-Unit Blood Transfusion Protocol
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
Baseline characteristics by cohort
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
29 years
STANDARD_DEVIATION 6 • n=7 Participants
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hemoglobin level at randomization
|
6.8 g/dL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
7.0 g/dL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
6.9 g/dL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until discharge from admission for delivery, an average of 2-3 daysTo determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Total Number of Units Transfused
|
1.2 units of blood
Standard Deviation 0.5
|
2.1 units of blood
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: From randomization until discharge from admission for delivery, an average of 2-3 daysTo determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Length of Stay
|
3.1 Days
Interval 2.5 to 3.8
|
3.4 Days
Interval 2.4 to 4.1
|
SECONDARY outcome
Timeframe: At 4-9 weeks after randomizationTo determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum.
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=29 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=27 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 4-9 weeks after randomization• To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Edinburgh Postnatal Depression Scale score at 4-9 weeks postpartum. EPDS scores range from 0-30, with higher scores (particularly above 10) are indicative of depression.
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Rate of Depression
|
4 score on a scale
Interval 1.0 to 11.0
|
5.5 score on a scale
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: 4-9 weeks after randomization• To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Multidimensional Fatigue Inventory scores at 4-9 weeks postpartum. This score ranges from 0-140 with higher scores indicating worse fatigue.
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Rate of Fatigue
|
44 score on a scale
Interval 34.0 to 55.0
|
53 score on a scale
Interval 38.0 to 70.0
|
SECONDARY outcome
Timeframe: 4-9 weeks after randomization• To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Maternal Attachment Inventory scores at 4-9 weeks postpartum. The possible range of scores is 26-104. Higher scores indicate higher maternal attachment to the infant.
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Maternal Attachment Inventory Scores
|
104 score on a scale
Interval 102.0 to 104.0
|
104 score on a scale
Interval 102.0 to 104.0
|
SECONDARY outcome
Timeframe: From randomization until 4-9 week postpartum visitDevelopment of any deep or superficial infection
Outcome measures
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 Participants
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Infection Rate
|
2 participants
|
1 participants
|
Adverse Events
Single-Unit Blood Transfusion Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple-Unit Blood Transfusion Protocol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-Unit Blood Transfusion Protocol
n=33 participants at risk
In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
Multiple-Unit Blood Transfusion Protocol
n=33 participants at risk
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Unrelated transfer to the ICU
|
0.00%
0/33 • Randomization until the time of the postpartum visit which occurred between 4 and 9 weeks after delivery.
The need for additional blood products and prolonged length of stay will not be considered adverse events as they represent possible issues related to the single-unit blood transfusion protocol. Adverse Events will be obtained by review of the subject's electronic medical record.
|
3.0%
1/33 • Number of events 1 • Randomization until the time of the postpartum visit which occurred between 4 and 9 weeks after delivery.
The need for additional blood products and prolonged length of stay will not be considered adverse events as they represent possible issues related to the single-unit blood transfusion protocol. Adverse Events will be obtained by review of the subject's electronic medical record.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place