Clinical trial NCT02729974: Use of ROTEM Intraoperatively in Women With Placenta Accreta
Official title: Use of ROTEM Intraoperatively in Women With Placenta Accreta
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Placenta Accreta
Keywords: thromboelastography
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of units of blood products transfused
timeFrame: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
Secondary outcomes:
measure: Number of hours spent in ICU
timeFrame: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
measure: Number of days in the hospital
timeFrame: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
measure: Presence of infection at the surgery site
timeFrame: From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier
measure: Readmission for other complications
timeFrame: For up to 6 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah, Department of OBGYN
name: Heather Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002.
citation: Upson K, Silver RM, Greene R, Lutomski J, Holt VL. Placenta accreta and maternal morbidity in the Republic of Ireland, 2005-2010. J Matern Fetal Neonatal Med. 2014 Jan;27(1):24-9. doi: 10.3109/14767058.2013.799654. Epub 2013 May 30.
citation: Eller AG, Bennett MA, Sharshiner M, Masheter C, Soisson AP, Dodson M, Silver RM. Maternal morbidity in cases of placenta accreta managed by a multidisciplinary care team compared with standard obstetric care. Obstet Gynecol. 2011 Feb;117(2 Pt 1):331-337. doi: 10.1097/AOG.0b013e3182051db2.
citation: Meyer AS, Meyer MA, Sorensen AM, Rasmussen LS, Hansen MB, Holcomb JB, Cotton BA, Wade CE, Ostrowski SR, Johansson PI. Thrombelastography and rotational thromboelastometry early amplitudes in 182 trauma patients with clinical suspicion of severe injury. J Trauma Acute Care Surg. 2014 Mar;76(3):682-90. doi: 10.1097/TA.0000000000000134.
citation: Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32.
citation: Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, Stanworth S, Brohi K. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012 Jul;10(7):1342-51. doi: 10.1111/j.1538-7836.2012.04752.x.
citation: Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.