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

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.

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).