Use of ROTEM Intraoperatively in Women With Placenta Accreta

Utah System of Higher Education (USHE)

Status: Invitation-only

Conditions: Placenta Accreta

Treatments: Procedure: standard treatment; Procedure: ROTEM

Study type: Interventional

Funder types: Other

Identifiers

NCT02729974

81113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

ROTEM

Experimental group

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.

Treatment:

Procedure: ROTEM

Standard treatment

Active Comparator group

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.

Treatment:

Procedure: standard treatment