Use of ROTEM Intraoperatively in Women With Placenta Accreta

Not Applicable

• Conditions: Placenta Accreta
• Interventions: Procedure: ROTEM; Procedure: standard treatment

• Registration Number: NCT02729974
• Lead Sponsor: University of Utah

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Study Start: 2016-05-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

• Non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROTEM	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.
Standard treatment	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
Readmission for other complications	For up to 6 weeks after surgery