Trial Outcomes & Findings for Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery (NCT NCT03064152)
NCT ID: NCT03064152
Last Updated: 2026-01-16
Results Overview
Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units within 48h of onset of PPH
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Results posted on
2026-01-16
Participant Flow
Participant milestones
| Measure |
Control
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
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|---|---|---|
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Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Control
n=26 Participants
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
n=23 Participants
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
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Total
n=49 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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36.3 years
STANDARD_DEVIATION 5.2 • n=9 Participants
|
36.0 years
STANDARD_DEVIATION 5.2 • n=6 Participants
|
36.2 years
STANDARD_DEVIATION 5.2 • n=9 Participants
|
|
Sex: Female, Male
Sex · Female
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26 Participants
n=9 Participants
|
23 Participants
n=6 Participants
|
49 Participants
n=9 Participants
|
|
Sex: Female, Male
Sex · Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=9 Participants
|
22 Participants
n=6 Participants
|
46 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
31 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
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weight (kg)
|
87 kg
STANDARD_DEVIATION 18.7 • n=9 Participants
|
82.5 kg
STANDARD_DEVIATION 15.7 • n=6 Participants
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85 kg
STANDARD_DEVIATION 16.5 • n=9 Participants
|
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height
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64.8 inches
STANDARD_DEVIATION 3.4 • n=9 Participants
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64.4 inches
STANDARD_DEVIATION 2.1 • n=6 Participants
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64.5 inches
STANDARD_DEVIATION 2.5 • n=9 Participants
|
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body mass index ( kg/m^2)
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33.7 kg/m^2
STANDARD_DEVIATION 9.4 • n=9 Participants
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30.7 kg/m^2
STANDARD_DEVIATION 6.0 • n=6 Participants
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32.0 kg/m^2
STANDARD_DEVIATION 7.0 • n=9 Participants
|
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gestational age
|
36.6 weeks
STANDARD_DEVIATION 1.9 • n=9 Participants
|
36.0 weeks
STANDARD_DEVIATION 2.3 • n=6 Participants
|
36.4 weeks
STANDARD_DEVIATION 2.0 • n=9 Participants
|
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gravidity
|
3 pregnancies
n=9 Participants
|
4 pregnancies
n=6 Participants
|
3 pregnancies
n=9 Participants
|
|
parity
|
1 deliveries
n=9 Participants
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1 deliveries
n=6 Participants
|
1 deliveries
n=9 Participants
|
|
twin gestation (n)
|
3 Participants
n=9 Participants
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3 Participants
n=6 Participants
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6 Participants
n=9 Participants
|
|
anesthesia type
combined spinal epidural
|
14 participants
n=9 Participants
|
15 participants
n=6 Participants
|
29 participants
n=9 Participants
|
|
anesthesia type
epidural
|
4 participants
n=9 Participants
|
3 participants
n=6 Participants
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7 participants
n=9 Participants
|
|
anesthesia type
general
|
2 participants
n=9 Participants
|
0 participants
n=6 Participants
|
2 participants
n=9 Participants
|
|
anesthesia type
spinal
|
6 participants
n=9 Participants
|
5 participants
n=6 Participants
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11 participants
n=9 Participants
|
|
delivery type
scheduled cesarean delivery
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20 participants
n=9 Participants
|
19 participants
n=6 Participants
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39 participants
n=9 Participants
|
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delivery type
unscheduled cesarean delivery
|
5 participants
n=9 Participants
|
3 participants
n=6 Participants
|
8 participants
n=9 Participants
|
|
delivery type
vaginal delivery
|
1 participants
n=9 Participants
|
1 participants
n=6 Participants
|
2 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units within 48h of onset of PPH
Outcome measures
| Measure |
Control
n=26 Participants
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
n=23 Participants
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay.
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|---|---|---|
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Total Blood Products Transfused Within 48h of Onset of PPH
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2 blood products
Interval 1.0 to 5.1
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1.4 blood products
Interval 0.0 to 7.0
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SECONDARY outcome
Timeframe: From the onset of PPH through 4 hours from leaving the operating room or within 4 hours from the last blood transfusion, whichever occurs later and on average 5 hours.Visual estimate in suction canister and sponges, or quantitative blood loss
Outcome measures
| Measure |
Control
n=26 Participants
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
n=23 Participants
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay.
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|---|---|---|
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Blood Loss
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2000 mL
Interval 1500.0 to 2600.0
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2100 mL
Interval 1800.0 to 2844.0
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SECONDARY outcome
Timeframe: within 2 weeks of deliveryNumber of participants needing admission to the intensive care unit within 2 weeks of delivery
Outcome measures
| Measure |
Control
n=26 Participants
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
n=23 Participants
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay.
|
|---|---|---|
|
Number of Participants With Admission to the Intensive Care Unit
|
1 Participants
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2 Participants
|
SECONDARY outcome
Timeframe: within 2 weeks of deliveryNumber of participants who required a hysterectomy to control postpartum hemorrhage.
Outcome measures
| Measure |
Control
n=26 Participants
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
n=23 Participants
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay.
|
|---|---|---|
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Number of Participants Who Required a Hysterectomy
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14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: within 2 weeks of deliveryNumber of participants who experienced maternal death after delivery.
Outcome measures
| Measure |
Control
n=26 Participants
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
|
ROTEM
n=23 Participants
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.
Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay.
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|---|---|---|
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Number of Participants Who Experienced Maternal Mortality
|
0 Participants
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0 Participants
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Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ROTEM
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place