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

NCT03064152 | Terminated Results DMC FDA Device

• 1 other identifier: 2016P001800
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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

  within 2 weeks of delivery

• Number of Participants Who Required a Hysterectomy

  within 2 weeks of delivery

• Number of Participants Who Experienced Maternal Mortality

  within 2 weeks of delivery

Study Arms (2)

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.

Device: Rotational Thromboelastometry

Interventions

Rotational Thromboelastometry DEVICE

ROTEM is a point-of-care coagulation assay.

Also known as: ROTEM

ROTEM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michaela K. Farber
• Organization: Brigham and Women's Hospital

mfarber@bwh.harvard.edu

6177591609

Study Officials

• Michaela K Farber, MD MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 24, 2017
• Study Start: September 1, 2017
• Primary Completion: February 7, 2020
• Study Completion: April 1, 2020
• Last Updated: January 16, 2026
• Results First Posted: June 18, 2021

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)