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

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.

Study Overview

• Status: Terminated
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Device: Rotational Thromboelastometry

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: 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.	Device: Rotational Thromboelastometry; ROTEM is a point-of-care coagulation assay.; Other Names: ROTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Blood Products Transfused	Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units	t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.

Secondary Outcome Measures

Outcome Measure	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	Need for admission to the intensive care unit after delivery	within 2 weeks of delivery
Number of Participants Who Required a Hysterectomy	Hysterectomy to control postpartum hemorrhage.	within 2 weeks of delivery
Number of Participants Who Experienced Maternal Mortality	Maternal death after delivery.	within 2 weeks of delivery

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Michaela K Farber, MD MS, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: May 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 2016P001800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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