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Use of ROTEM Intraoperatively in Women With Placenta Accreta (ROTEM)

Primary Purpose

Placenta Accreta

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ROTEM
standard treatment
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placenta Accreta focused on measuring thromboelastography

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.

Exclusion Criteria:

  • Non-English speaking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ROTEM

    Standard treatment

    Arm Description

    Participants randomized to this arm will have rapid testing of hematocrit and clotting function every 30 minutes during the hysterectomy portion of their surgery for placenta accreta, with transfusion of blood products based on defined abnormalities in these tests.

    Participants randomized to this arm will have standard visual assessment of blood loss and standard laboratory studies to assess blood count and clotting function when indicated during the hysterectomy portion of their surgery for placenta accreta. Transfusion of blood products will be based on abnormalities of these test results.

    Outcomes

    Primary Outcome Measures

    Number of units of blood products transfused

    Secondary Outcome Measures

    Number of hours spent in ICU
    Number of days in the hospital
    Presence of infection at the surgery site
    Readmission for other complications

    Full Information

    First Posted
    March 18, 2016
    Last Updated
    January 5, 2023
    Sponsor
    University of Utah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02729974
    Brief Title
    Use of ROTEM Intraoperatively in Women With Placenta Accreta
    Acronym
    ROTEM
    Official Title
    Use of ROTEM Intraoperatively in Women With Placenta Accreta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Utah

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the use of rapid tests for hematocrit and clotting function in women undergoing surgery for placenta accreta. Half of participants will have these rapid tests performed during surgery to guide blood product transfusion and the other half will have standard lab tests performed to guide transfusion.
    Detailed Description
    Placenta accreta has become an increasingly common pregnancy complication. Serious complications are common in patients with placenta accreta, including hemorrhage, transfusion of blood products, abdominal organ injury, bladder surgery, and ICU admission. Hemorrhage, or excessive blood loss, is the most common complication and often results in impaired ability for the body to form blood clots normally. The development of rapid testing of hematocrit and clotting function may allow for earlier identification of patients who have severe blood loss and development of clotting abnormalities. The investigators are testing whether use of this technology in patients undergoing surgery for placenta accreta, with earlier identification of patients with severe blood loss or clotting abnormality, will result in a lower need for transfusion and fewer complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Accreta
    Keywords
    thromboelastography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ROTEM
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm will have rapid testing of hematocrit and clotting function every 30 minutes during the hysterectomy portion of their surgery for placenta accreta, with transfusion of blood products based on defined abnormalities in these tests.
    Arm Title
    Standard treatment
    Arm Type
    Active Comparator
    Arm Description
    Participants randomized to this arm will have standard visual assessment of blood loss and standard laboratory studies to assess blood count and clotting function when indicated during the hysterectomy portion of their surgery for placenta accreta. Transfusion of blood products will be based on abnormalities of these test results.
    Intervention Type
    Procedure
    Intervention Name(s)
    ROTEM
    Intervention Description
    rapid testing of blood clot formation
    Intervention Type
    Procedure
    Intervention Name(s)
    standard treatment
    Intervention Description
    visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
    Primary Outcome Measure Information:
    Title
    Number of units of blood products transfused
    Time Frame
    From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
    Secondary Outcome Measure Information:
    Title
    Number of hours spent in ICU
    Time Frame
    From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
    Title
    Number of days in the hospital
    Time Frame
    From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
    Title
    Presence of infection at the surgery site
    Time Frame
    From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
    Title
    Readmission for other complications
    Time Frame
    For up to 6 weeks after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow. Exclusion Criteria: Non-English speaking
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heather Campbell, MD
    Organizational Affiliation
    University of Utah, Department of OBGYN
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23466142
    Citation
    Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002.
    Results Reference
    background
    PubMed Identifier
    23638753
    Citation
    Upson K, Silver RM, Greene R, Lutomski J, Holt VL. Placenta accreta and maternal morbidity in the Republic of Ireland, 2005-2010. J Matern Fetal Neonatal Med. 2014 Jan;27(1):24-9. doi: 10.3109/14767058.2013.799654. Epub 2013 May 30.
    Results Reference
    background
    PubMed Identifier
    21309195
    Citation
    Eller AG, Bennett MA, Sharshiner M, Masheter C, Soisson AP, Dodson M, Silver RM. Maternal morbidity in cases of placenta accreta managed by a multidisciplinary care team compared with standard obstetric care. Obstet Gynecol. 2011 Feb;117(2 Pt 1):331-337. doi: 10.1097/AOG.0b013e3182051db2.
    Results Reference
    background
    PubMed Identifier
    24553534
    Citation
    Meyer AS, Meyer MA, Sorensen AM, Rasmussen LS, Hansen MB, Holcomb JB, Cotton BA, Wade CE, Ostrowski SR, Johansson PI. Thrombelastography and rotational thromboelastometry early amplitudes in 182 trauma patients with clinical suspicion of severe injury. J Trauma Acute Care Surg. 2014 Mar;76(3):682-90. doi: 10.1097/TA.0000000000000134.
    Results Reference
    background
    PubMed Identifier
    23971232
    Citation
    Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32.
    Results Reference
    background
    PubMed Identifier
    22519961
    Citation
    Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, Stanworth S, Brohi K. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012 Jul;10(7):1342-51. doi: 10.1111/j.1538-7836.2012.04752.x.
    Results Reference
    background
    PubMed Identifier
    19459866
    Citation
    Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.
    Results Reference
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    Use of ROTEM Intraoperatively in Women With Placenta Accreta

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