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

Description

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 Start Date

September, 01 2017

Estimated Completion Date

September 2018

Interventions

  • Device: Rotational Thromboelastometry

Study ID

Brigham and Women's Hospital -- 2016P001800

Status

Recruiting

Trial ID

NCT03064152

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

100

Sponsor

Brigham and Women's Hospital

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).

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michaela K Farber MD MS 617-732-8220 mkfarber@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michaela K Farber MD MS 617-732-8220 mkfarber@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michaela K Farber MD MS 617-732-8220 mkfarber@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michaela K Farber MD MS 617-732-8220 mkfarber@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michaela K Farber MD MS 617-732-8220 mkfarber@partners.org

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