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Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03064152
Recruitment Status : Terminated (slow enrollment, outcome measures collected but actual enrollment is below target enrollment)
First Posted : February 24, 2017
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Michaela Kristina Farber, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Postpartum Hemorrhage
Intervention Device: Rotational Thromboelastometry
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control ROTEM
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 26 23
Completed 26 23
Not Completed 0 0
Arm/Group Title Control ROTEM Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 26 23 49
Hide Baseline Analysis Population Description
same as Participant Flow
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 23 participants 49 participants
36.3  (5.2) 36.0  (5.2) 36.2  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Sex Number Analyzed 26 participants 23 participants 49 participants
Female
26
 100.0%
23
 100.0%
49
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
Hispanic or Latino
0
   0.0%
1
   4.3%
1
   2.0%
Not Hispanic or Latino
24
  92.3%
22
  95.7%
46
  93.9%
Unknown or Not Reported
2
   7.7%
0
   0.0%
2
   4.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   7.7%
4
  17.4%
6
  12.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  19.2%
5
  21.7%
10
  20.4%
White
17
  65.4%
14
  60.9%
31
  63.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   7.7%
0
   0.0%
2
   4.1%
weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 26 participants 23 participants 49 participants
87  (18.7) 82.5  (15.7) 85  (16.5)
height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 26 participants 23 participants 49 participants
64.8  (3.4) 64.4  (2.1) 64.5  (2.5)
body mass index ( kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 26 participants 23 participants 49 participants
33.7  (9.4) 30.7  (6.0) 32.0  (7.0)
gestational age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 26 participants 23 participants 49 participants
36.6  (1.9) 36.0  (2.3) 36.4  (2.0)
gravidity  
Median (Inter-Quartile Range)
Unit of measure:  Pregnancies
Number Analyzed 26 participants 23 participants 49 participants
3
(2 to 4)
4
(2 to 5)
3
(2 to 5)
parity  
Median (Inter-Quartile Range)
Unit of measure:  Deliveries
Number Analyzed 26 participants 23 participants 49 participants
1
(1 to 2)
1
(1 to 2)
1
(1 to 2)
twin gestation (n)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 49 participants
3
  11.5%
3
  13.0%
6
  12.2%
anesthesia type  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 26 participants 23 participants 49 participants
combined spinal epidural 14 15 29
epidural 4 3 7
general 2 0 2
spinal 6 5 11
delivery type  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 26 participants 23 participants 49 participants
scheduled cesarean delivery 20 19 39
unscheduled cesarean delivery 5 3 8
vaginal delivery 1 1 2
1.Primary Outcome
Title Total Blood Products Transfused
Hide Description Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units
Time Frame t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control ROTEM
Hide Arm/Group Description:
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.

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.
Overall Number of Participants Analyzed 26 23
Median (Inter-Quartile Range)
Unit of Measure: blood products
2
(1 to 5.1)
1.4
(0 to 7)
2.Secondary Outcome
Title Blood Loss
Hide Description Visual estimate in suction canister and sponges, or quantitative blood loss
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control ROTEM
Hide Arm/Group Description:
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.

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.
Overall Number of Participants Analyzed 26 23
Median (Inter-Quartile Range)
Unit of Measure: mL
2000
(1500 to 2600)
2100
(1800 to 2844)
3.Secondary Outcome
Title Number of Participants With Admission to the Intensive Care Unit
Hide Description Need for admission to the intensive care unit after delivery
Time Frame within 2 weeks of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control ROTEM
Hide Arm/Group Description:
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.

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.
Overall Number of Participants Analyzed 26 23
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.8%
2
   8.7%
4.Secondary Outcome
Title Number of Participants Who Required a Hysterectomy
Hide Description Hysterectomy to control postpartum hemorrhage.
Time Frame within 2 weeks of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control ROTEM
Hide Arm/Group Description:
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.

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.
Overall Number of Participants Analyzed 26 23
Measure Type: Count of Participants
Unit of Measure: Participants
14
  53.8%
13
  56.5%
5.Secondary Outcome
Title Number of Participants Who Experienced Maternal Mortality
Hide Description Maternal death after delivery.
Time Frame within 2 weeks of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control ROTEM
Hide Arm/Group Description:
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.

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.
Overall Number of Participants Analyzed 26 23
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 32 months
Adverse Event Reporting Description As described by clinicaltrials.gov.
 
Arm/Group Title Control ROTEM
Hide Arm/Group Description 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.

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.
All-Cause Mortality
Control ROTEM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/23 (0.00%) 
Hide Serious Adverse Events
Control ROTEM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control ROTEM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/23 (0.00%) 
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michaela K. Farber
Organization: Brigham and Women's Hospital
Phone: 6177591609
EMail: mfarber@bwh.harvard.edu
Layout table for additonal information
Responsible Party: Michaela Kristina Farber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03064152    
Other Study ID Numbers: 2016P001800
First Submitted: February 17, 2017
First Posted: February 24, 2017
Results First Submitted: April 22, 2021
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021