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

Primary Purpose

Postpartum Hemorrhage

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotational Thromboelastometry
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

ROTEM

Arm 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.

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.

Outcomes

Primary Outcome Measures

Total Blood Products Transfused
Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units

Secondary Outcome Measures

Blood Loss
Visual estimate in suction canister and sponges, or quantitative blood loss
Number of Participants With Admission to the Intensive Care Unit
Need for admission to the intensive care unit after delivery
Number of Participants Who Required a Hysterectomy
Hysterectomy to control postpartum hemorrhage.
Number of Participants Who Experienced Maternal Mortality
Maternal death after delivery.

Full Information

First Posted
February 17, 2017
Last Updated
May 23, 2021
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03064152
Brief Title
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
Official Title
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment, outcome measures collected but actual enrollment is below target enrollment
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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 Title
ROTEM
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Rotational Thromboelastometry
Other Intervention Name(s)
ROTEM
Intervention Description
ROTEM is a point-of-care coagulation assay.
Primary Outcome Measure Information:
Title
Total Blood Products Transfused
Description
Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units
Time Frame
t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Secondary Outcome Measure Information:
Title
Blood Loss
Description
Visual estimate in suction canister and sponges, or quantitative 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 and on average 5 hours.
Title
Number of Participants With Admission to the Intensive Care Unit
Description
Need for admission to the intensive care unit after delivery
Time Frame
within 2 weeks of delivery
Title
Number of Participants Who Required a Hysterectomy
Description
Hysterectomy to control postpartum hemorrhage.
Time Frame
within 2 weeks of delivery
Title
Number of Participants Who Experienced Maternal Mortality
Description
Maternal death after delivery.
Time Frame
within 2 weeks of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela K Farber, MD MS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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