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Does the introduction of rotational thromboelastometry (ROTEM)-guided transfusion management for patients undergoing surgical intervention for post-partum haemorrhage (PPH) affect blood product use and patient outcomes?

Effects of rotational thromboelastometry (ROTEM)-guided transfusion management for patients undergoing surgical intervention for post-partum haemorrhage (PPH): an observational study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001061123
Enrollment
900
Registered
2019-07-30
Start date
2018-02-23
Completion date
2019-07-26
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Post-partum haemorrhage (PPH) is a common obstetric complication and a major cause of maternal mortality and morbidity in Australia. Treatment of PPH often involves significant healthcare resources, including blood products, operating theatre time, prolonged hospital length of stay, and in severe cases, admission to intensive care. PPH is often associated with, and is exacerbated by, abnormalities of haemostasis. Traditional coagulation tests are insensitive at predicting severity of PPH and guiding its management, with a paucity of evidence supporting their use for transfusion management in the peri-operative setting. Rotational thromboelastometry (ROTEM) is a point-of-care test of whole blood coagulation that provides rapid information about time to clot formation, strength of clot and presence of fibrinolysis. ROTEM can be used to help guide replacement coagulation treatments in peri-operative settings. ROTEM was introduced in June 2016 in the operating suite at Sunshine Hospital, alongside a transfusion algorithm. This study aims to examine the effect that the introduction of ROTEM-guided transfusion management has had on the utilisation of blood products and on clinical outcomes in patients with PPH requiring surgical management. This will help us to better understand the role and benefits of ROTEM in the peri-operative setting, which will in turn benefit patient care by better informing future management of PPH and related clinical conditions.

Interventions

Rotational elastometry (ROTEM) is a point-of-care test of whole blood coagulation that provides rapid information about time to clot formation, strength of clot and presence of fibrinolysis, and can be used to guide replacement of coagulation factors in peri-operative settings. Our hospital introduced ROTEM-guided transfusion management for patients with postpartum haemorrhage (PPH) in the operating theatre in June 2016. A departmental guideline was developed and implemented, including the perfo

Rotational elastometry (ROTEM) is a point-of-care test of whole blood coagulation that provides rapid information about time to clot formation, strength of clot and presence of fibrinolysis, and can be used to guide replacement of coagulation factors in peri-operative settings. Our hospital introduced ROTEM-guided transfusion management for patients with postpartum haemorrhage (PPH) in the operating theatre in June 2016. A departmental guideline was developed and implemented, including the performance of a ROTEM test by the anaesthetist for such patients and correction of coagulation deficits according to ROTEM results (the first guideline shown at the website https://www.rotemresource.com/). The exposure group are patients with PPH treated in the operating theatre after the introduction of ROTEM, specifically, from September 2017 to approximately mid-2018. No additional information or procedures were required from participants for the study, i.e. all data collected for the study is from the medical records. No alteration to their clinical management occurred as a result of the study, hence, waiver of consent was applied and approved by our hospital's research ethics committee. The data collected were from a single episode of care for each patient (i.e. the episode in which they experienced PPH), there was no period of observation following this.

Sponsors

Dr Yiying (Sally) Tsang
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who fulfil our institution’s definition of post-partum haemorrhage and who require management in the operating suite, namely: a) Patients delivering vaginally with estimated blood loss (EBL) > 500ml, who require operative management for PPH within the first 24 hours; and b) Patients delivering by Caesarean section (CS) with EBL >750ml.

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026