Use of ROTEM Intraoperatively in Women With Placenta Accreta (ROTEM)
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|ClinicalTrials.gov Identifier: NCT02729974|
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Placenta Accreta||Procedure: ROTEM Procedure: standard treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of ROTEM Intraoperatively in Women With Placenta Accreta|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
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.
rapid testing of blood clot formation
Active Comparator: 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.
Procedure: standard treatment
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729974
|Principal Investigator:||Heather Campbell, MD||University of Utah, Department of OBGYN|