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

Stopped early · Not applicable

Conditions studied: Postpartum Hemorrhage

In brief

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.

Key facts

Study ID

NCT03064152

Run by

Brigham and Women's Hospital

People needed

49

Starts

2017-09-01

Expected to finish

2020-04-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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
• placenta previa (current or resolved within 4 weeks of delivery) or low-lying placenta
• active bleeding on admission prior to delivery

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).

Where it is running

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

Full record on ClinicalTrials.gov

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