Clinical Trial: Use of ROTEM Intraoperatively in Women With Placenta Accreta

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Use of ROTEM Intraoperatively in Women With Placenta Accreta

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 Summary:

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.


Sponsor: University of Utah

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • Readmission for other complications [ Time Frame: For up to 6 weeks after surgery ]


Original Secondary Outcome: Same as current

Information By: University of Utah

Dates:
Date Received: March 18, 2016
Date Started: March 2016
Date Completion: March 2019
Last Updated: April 28, 2017
Last Verified: April 2017