Use of ROTEM Intraoperatively in Women With Placenta Accreta
NCT ID: NCT02729974
Last Updated: 2024-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
40 participants
INTERVENTIONAL
2016-05-08
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ROTEM
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.
ROTEM
rapid testing of blood clot formation
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.
standard treatment
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
Interventions
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ROTEM
rapid testing of blood clot formation
standard treatment
visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
FEMALE
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Heather Campbell
Principal Investigator
Principal Investigators
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Heather Campbell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah, Department of OBGYN
References
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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.
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.
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.
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.
Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32.
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.
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.
Other Identifiers
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81113
Identifier Type: -
Identifier Source: org_study_id
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