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

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ClinicalTrials.gov Identifier: NCT02729974
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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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.

Condition or disease Intervention/treatment Phase
Placenta Accreta Procedure: ROTEM Procedure: standard treatment Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of ROTEM Intraoperatively in Women With Placenta Accreta
Study Start Date : March 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ROTEM
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.
 Procedure: ROTEM
rapid testing of blood clot formation
Active Comparator: Standard treatment
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.
 Procedure: standard treatment
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Readmission for other complications [ Time Frame: For up to 6 weeks after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729974


Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Heather Campbell, MD University of Utah, Department of OBGYN
More Information
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Publications:

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02729974    
Other Study ID Numbers: 81113
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Utah:
thromboelastography
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases