Clinical Trials Directory

Trials / Completed

CompletedNCT02729974

Use of ROTEM Intraoperatively in Women With Placenta Accreta

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
University of Utah · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREROTEMrapid testing of blood clot formation
PROCEDUREstandard treatmentvisual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated

Timeline

Start date
2016-05-08
Primary completion
2024-12-01
Completion
2025-12-01
First posted
2016-04-06
Last updated
2026-04-15

Source: ClinicalTrials.gov record NCT02729974. Inclusion in this directory is not an endorsement.