Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
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|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
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|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Device: Rotational Thromboelastometry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||February 7, 2020|
|Actual Study Completion Date :||April 1, 2020|
No Intervention: 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.
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.
Device: Rotational Thromboelastometry
ROTEM is a point-of-care coagulation assay.
Other Name: ROTEM
- Total Blood Products Transfused [ Time Frame: 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
- 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. ]Visual estimate in suction canister and sponges, or quantitative blood loss
- Number of Participants With Admission to the Intensive Care Unit [ Time Frame: within 2 weeks of delivery ]Need for admission to the intensive care unit after delivery
- Number of Participants Who Required a Hysterectomy [ Time Frame: within 2 weeks of delivery ]Hysterectomy to control postpartum hemorrhage.
- Number of Participants Who Experienced Maternal Mortality [ Time Frame: within 2 weeks of delivery ]Maternal death after delivery.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
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:
- Cesarean delivery with moderate or high risk for PPH (see below).
- Cesarean delivery with acute PPH of > 1000 mL and blood products ordered from the blood bank.
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064152
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Michaela K Farber, MD MS||Brigham and Women's Hospital|
Documents provided by Michaela Kristina Farber, MD, Brigham and Women's Hospital:
|Responsible Party:||Michaela Kristina Farber, MD, Principle Investigator, Brigham and Women's Hospital|
|Other Study ID Numbers:||
|First Posted:||February 24, 2017 Key Record Dates|
|Results First Posted:||June 18, 2021|
|Last Update Posted:||June 18, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Obstetric Labor Complications