Use of ROTEM Intraoperatively in Women With Placenta Accreta

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of ROTEM Intraoperatively in Women With Placenta Accreta

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: ROTEM
* Procedure: standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROTEM<br>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<br>* rapid testing of blood clot formation<br>|
| Active Comparator: Standard treatment<br>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<br>* visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of units of blood products transfused |  | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hours spent in ICU |  | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier | 
| Number of days in the hospital |  | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier | 
| Presence of infection at the surgery site |  | From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier | 
| Readmission for other complications |  | For up to 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboelastography