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

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

Sponsors

Lead sponsor: Brigham and Women's Hospital

Source Brigham and Women's Hospital
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.

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.

Overall Status Recruiting
Start Date September 1, 2017
Completion Date April 1, 2020
Primary Completion Date February 7, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of blood products transfused t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Secondary Outcome
Measure Time Frame
ROTEM values Drawn from the onset of PPH through the time of the last blood sampling within 4 hours from leaving the operating room or within 4 hours from the last blood transfusion, whichever occurs later.
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.
Admission to the intensive care unit within 2 weeks of delivery
Need for additional post-delivery procedures for bleeding within 2 weeks of delivery
Hysterectomy within 2 weeks of delivery
Maternal mortality within 2 weeks of delivery
Enrollment 100
Condition
Intervention

Intervention type: Device

Intervention name: Rotational Thromboelastometry

Description: ROTEM is a point-of-care coagulation assay.

Arm group label: ROTEM

Other name: ROTEM

Eligibility

Criteria:

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

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michaela K Farber, MD MS Principal Investigator Brigham and Women's Hospital
Overall Contact

Last name: Michaela K Farber, MD MS

Phone: 617-732-8220

Email: [email protected]

Location
facility status contact investigator
Brigham and Women's Hospital Recruiting Michaela K Farber, MD MS 617-732-8220 [email protected] Michaela K Farber, MD MS Principal Investigator
Location Countries

United States

Verification Date

February 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Brigham and Women's Hospital

Investigator full name: Michaela Kristina Farber, MD

Investigator title: Principle Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control

Arm group type: No Intervention

Description: 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.

Arm group label: ROTEM

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov