Postpartum Hemorrhage
Conditions
Brief summary
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.
Detailed description
Postpartum hemorrhage is increasing in incidence in the United States, renewing interest in targeted approaches to transfusion during cesarean delivery. ROTEM-based transfusion for PPH has been advocated as a mechanism to lower overall requirement of blood components transfused and lower the incidence of transfusion-associated pulmonary morbidity in a small study of women undergoing cesarean delivery. However, larger-scale randomized evaluation of this transfusion approach is warranted for women who experience hemorrhage after vaginal or cesarean delivery. A lower serum fibrinogen level (\< 200 mg/dL) at the onset of PPH has a positive predictive value of 100% for progression to severe PPH. However, serum fibrinogen testing has a turnaround time of one hour and is therefore not useful for acute management of PPH. ROTEM provides point-of-care results that have been validated as surrogate markers for serum fibrinogen, within 10 minutes. However, whether ROTEM data alters empiric management of acute PPH is unknown. A comparison of transfusion management decisions and costs incurred for transfused products and transfusion-related morbidity (duration of hospitalization, intensive care unit, respiratory complications) will be performed.
Interventions
ROTEM is a point-of-care coagulation assay.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists (ASA) II or III health status (minimal to no systemic disease), age between 18 and 50 yrs, singleton pregnancies admitted for labor and delivery anticipated or actual PPH, or anticipated transfusion of blood products. This will be defined by one or more of the following eligibility criteria: 1. Cesarean delivery with moderate or high risk for PPH (see below). 2. Cesarean delivery with acute PPH of \> 1000 mL and blood products ordered from the blood bank. 3. Vaginal delivery with acute PPH of \> 500 mL and blood products ordered from the blood bank. For criterion #1, moderate risk for PPH is defined by one or more of the following features: * prior cesarean delivery in labor * prior cesarean delivery with known adhesive disease of the placenta * multiple gestation * \>4 previous vaginal births * chorioamnionitis with maternal temperature \> 101 degrees Fahrenheit * history of previous PPH * large uterine fibroids (\> 5 cm) * second stage of labor (10cm cervical dilation to delivery) \> 3 hours High risk for postpartum hemorrhage is defined by one or more of the following features: * suspected placenta accreta by pre-delivery ultrasound findings * placenta previa (current or resolved within 4 weeks of delivery) or low-lying placenta * active bleeding on admission prior to delivery
Exclusion criteria
* known coagulation defect prior to delivery including inherited (hemophilia A, von Willebrand disease, thrombocytopenia, other) or iatrogenic causes (anticoagulation therapy), refusal to accept blood transfusion (Jehovah's Witness, other).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Products Transfused Within 48h of Onset of PPH | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | 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 |
| Number of Participants With Admission to the Intensive Care Unit | within 2 weeks of delivery | Number of participants needing admission to the intensive care unit within 2 weeks of delivery |
| Number of Participants Who Required a Hysterectomy | within 2 weeks of delivery | Number of participants who required a hysterectomy to control postpartum hemorrhage. |
| Number of Participants Who Experienced Maternal Mortality | within 2 weeks of delivery | Number of participants who experienced maternal death after delivery. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichaela K Farber, MD MS
Brigham and Women's Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 23 |
| Total | 49 |
Baseline characteristics
| Characteristic | ROTEM | Total | Control |
|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 5.2 | 36.2 years STANDARD_DEVIATION 5.2 | 36.3 years STANDARD_DEVIATION 5.2 |
| anesthesia type combined spinal epidural | 15 participants | 29 participants | 14 participants |
| anesthesia type epidural | 3 participants | 7 participants | 4 participants |
| anesthesia type general | 0 participants | 2 participants | 2 participants |
| anesthesia type spinal | 5 participants | 11 participants | 6 participants |
| body mass index ( kg/m^2) | 30.7 kg/m^2 STANDARD_DEVIATION 6 | 32.0 kg/m^2 STANDARD_DEVIATION 7 | 33.7 kg/m^2 STANDARD_DEVIATION 9.4 |
| delivery type scheduled cesarean delivery | 19 participants | 39 participants | 20 participants |
| delivery type unscheduled cesarean delivery | 3 participants | 8 participants | 5 participants |
| delivery type vaginal delivery | 1 participants | 2 participants | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 46 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| gestational age | 36.0 weeks STANDARD_DEVIATION 2.3 | 36.4 weeks STANDARD_DEVIATION 2 | 36.6 weeks STANDARD_DEVIATION 1.9 |
| gravidity | 4 pregnancies | 3 pregnancies | 3 pregnancies |
| height | 64.4 inches STANDARD_DEVIATION 2.1 | 64.5 inches STANDARD_DEVIATION 2.5 | 64.8 inches STANDARD_DEVIATION 3.4 |
| parity | 1 deliveries | 1 deliveries | 1 deliveries |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 31 Participants | 17 Participants |
| Sex: Female, Male Sex Female | 23 Participants | 49 Participants | 26 Participants |
| Sex: Female, Male Sex Male | 0 Participants | 0 Participants | 0 Participants |
| twin gestation (n) | 3 Participants | 6 Participants | 3 Participants |
| weight (kg) | 82.5 kg STANDARD_DEVIATION 15.7 | 85 kg STANDARD_DEVIATION 16.5 | 87 kg STANDARD_DEVIATION 18.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 23 |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 23 |
Outcome results
Primary
Total Blood Products Transfused Within 48h of 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
Time frame: t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Total Blood Products Transfused Within 48h of Onset of PPH | 2 blood products |
| ROTEM | Total Blood Products Transfused Within 48h of Onset of PPH | 1.4 blood products |
Secondary
Blood Loss
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Blood Loss | 2000 mL |
| ROTEM | Blood Loss | 2100 mL |
Secondary
Number of Participants Who Experienced Maternal Mortality
Number of participants who experienced maternal death after delivery.
Time frame: within 2 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Who Experienced Maternal Mortality | 0 Participants |
| ROTEM | Number of Participants Who Experienced Maternal Mortality | 0 Participants |
Secondary
Number of Participants Who Required a Hysterectomy
Number of participants who required a hysterectomy to control postpartum hemorrhage.
Time frame: within 2 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Who Required a Hysterectomy | 14 Participants |
| ROTEM | Number of Participants Who Required a Hysterectomy | 13 Participants |
Secondary
Number of Participants With Admission to the Intensive Care Unit
Number of participants needing admission to the intensive care unit within 2 weeks of delivery
Time frame: within 2 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Admission to the Intensive Care Unit | 1 Participants |
| ROTEM | Number of Participants With Admission to the Intensive Care Unit | 2 Participants |