Use of ROTEM Intraoperatively in Women With Placenta Accreta

NCT02729974 | Completed

• 1 other identifier: 81113
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placenta Accreta

Keywords

thromboelastography

Outcome Measures

Primary Outcomes (1)

• Number of units of blood products transfused

  From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier

Secondary Outcomes (4)

• Number of hours spent in ICU

  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

  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

  From the time of surgery up to 10 days, or until discharge from the hospital if this occurs earlier

• Readmission for other complications

  For up to 6 weeks after surgery

Study Arms (2)

ROTEM

EXPERIMENTAL

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.

Procedure: ROTEM

Standard treatment

ACTIVE COMPARATOR

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

Interventions

ROTEM PROCEDURE

rapid testing of blood clot formation

ROTEM

standard treatment PROCEDURE

visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated

Standard treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with placenta accreta during pregnancy who are scheduled to have delivery by cesarean section with hysterectomy to follow.

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• University of Utah: lead

Related Publications (7)

• 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.

  PMID: 23466142 BACKGROUND

• 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.

  PMID: 23638753 BACKGROUND

• 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.

  PMID: 21309195 BACKGROUND

• 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.

  PMID: 24553534 BACKGROUND

• Brazzel C. Thromboelastography-guided transfusion Therapy in the trauma patient. AANA J. 2013 Apr;81(2):127-32.

  PMID: 23971232 BACKGROUND

• 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.

  PMID: 22519961 BACKGROUND

• 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.

  PMID: 19459866 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Heather Campbell, MD

  University of Utah, Department of OBGYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 6, 2016
• Study Start: May 8, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share