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

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ClinicalTrials.gov Identifier: NCT03064152
Recruitment Status : Terminated (slow enrollment, outcome measures collected but actual enrollment is below target enrollment)
First Posted : February 24, 2017
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Michaela Kristina Farber, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 24, 2017
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date February 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
Number of blood products transfused [ Time Frame: t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
  • ROTEM values [ Time Frame: 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 [ Time Frame: 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. ]
    Visual estimate in suction canister and sponges, quantitative blood loss, and pre- vs postdelivery hemoglobin values.
  • Admission to the intensive care unit [ Time Frame: within 2 weeks of delivery ]
  • Need for additional post-delivery procedures for bleeding [ Time Frame: within 2 weeks of delivery ]
    intrauterine compression device, surgical reoperation (laparotomy, dilatation and curettage), interventional radiology for uterine artery embolization
  • Hysterectomy [ Time Frame: within 2 weeks of delivery ]
  • Maternal mortality [ Time Frame: within 2 weeks of delivery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
Official Title  ICMJE Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE Device: Rotational Thromboelastometry
ROTEM is a point-of-care coagulation assay.
Other Name: ROTEM
Study Arms  ICMJE
  • No Intervention: Control
    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.
  • Experimental: ROTEM
    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.
    Intervention: Device: Rotational Thromboelastometry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2020)
49
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2017)
100
Actual Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion Date February 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03064152
Other Study ID Numbers  ICMJE 2016P001800
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michaela Kristina Farber, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michaela K Farber, MD MS Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP