Not provided
Not provided
Not provided
Not provided
Not provided
slow enrollment, outcome measures collected but actual enrollment is below target enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational Thromboelastometry | Device | ROTEM is a point-of-care coagulation assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Visual estimate in suction canister and sponges, or quantitative 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. |
| Number of Participants With Admission to the Intensive Care Unit |
Not provided
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:
For criterion #1, moderate risk for PPH is defined by one or more of the following features:
High risk for postpartum hemorrhage is defined by one or more of the following features:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michaela K Farber, MD MS | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
same as Participant Flow
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | blood products | t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH. |
|
Each enrolled participant was directly involved in the study for approximately 3-5 hours for the duration of their time in the operating room, until the end of follow-up, up to 2 weeks postpartum.
As described by clinicaltrials.gov.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michaela K. Farber | Brigham and Women's Hospital | 6177591609 | mfarber@bwh.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2021 | Apr 22, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of participants needing admission to the intensive care unit within 2 weeks of delivery |
| within 2 weeks of delivery |
| Number of Participants Who Required a Hysterectomy | Number of participants who required a hysterectomy to control postpartum hemorrhage. | within 2 weeks of delivery |
| Number of Participants Who Experienced Maternal Mortality | Number of participants who experienced maternal death after delivery. | within 2 weeks of delivery |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| weight (kg) | Mean | Standard Deviation | kg |
|
| height | Mean | Standard Deviation | inches |
|
| body mass index ( kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| gestational age | Mean | Standard Deviation | weeks |
|
| gravidity | Median | Inter-Quartile Range | pregnancies |
|
| parity | Median | Inter-Quartile Range | deliveries |
|
| twin gestation (n) | Count of Participants | Participants |
|
| anesthesia type | Number | participants |
|
| delivery type | Number | participants |
|
| OG001 | 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. Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay. |
|
|
| Secondary | Blood Loss | Visual estimate in suction canister and sponges, or quantitative blood loss | Posted | Median | Inter-Quartile Range | mL | 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. |
|
|
|
| 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 | Posted | Count of Participants | Participants | within 2 weeks of delivery |
|
|
|
| Secondary | Number of Participants Who Required a Hysterectomy | Number of participants who required a hysterectomy to control postpartum hemorrhage. | Posted | Count of Participants | Participants | within 2 weeks of delivery |
|
|
|
| Secondary | Number of Participants Who Experienced Maternal Mortality | Number of participants who experienced maternal death after delivery. | Posted | Count of Participants | Participants | within 2 weeks of delivery |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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. Rotational Thromboelastometry: ROTEM is a point-of-care coagulation assay. | 0 | 23 | 0 | 23 | 0 | 23 |
Not provided
Not provided
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |