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Trial registered on ANZCTR


Registration number
ACTRN12619001061123
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
30/07/2019
Date last updated
16/09/2019
Date data sharing statement initially provided
30/07/2019
Date results information initially provided
16/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
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?
Scientific title
Effects of rotational thromboelastometry (ROTEM)-guided transfusion management for patients undergoing surgical intervention for post-partum haemorrhage (PPH): an observational study
Secondary ID [1] 298601 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post partum haemorrhage 313447 0
Condition category
Condition code
Reproductive Health and Childbirth 311883 311883 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 314858 0
Not applicable
Comparator / control treatment
The control group are patients with PPH requiring surgical management in the operating theatre who were treated from August 2015 to June 2016 (i.e. prior to the introduction of ROTEM).
Control group
Historical

Outcomes
Primary outcome [1] 320547 0
Percentage of patients requiring red cell transfusion.
Accessed from medical records
Timepoint [1] 320547 0
Within 24 hours post partum
Secondary outcome [1] 371963 0
Volume of packed red cells transfused (units)
From medical records
Timepoint [1] 371963 0
Within 24 hours post partum
Secondary outcome [2] 371964 0
Volume of total blood loss (mls)
From medical records
Timepoint [2] 371964 0
Within 24 hours post partum
Secondary outcome [3] 371965 0
Percentage of patients transfused with fresh frozen plasma (FFP)
From medical records
Timepoint [3] 371965 0
Within 24 hours post partum
Secondary outcome [4] 371966 0
Percentage of patients transfused with cryoprecipitate
From medical records
Timepoint [4] 371966 0
Within 24 hours post partum
Secondary outcome [5] 371967 0
Percentage of patients transfused with platelets
From medical records
Timepoint [5] 371967 0
Within 24 hours post partum
Secondary outcome [6] 371968 0
Volume of FFP transfused (units)
From medical records
Timepoint [6] 371968 0
Within 24 hours post partum
Secondary outcome [7] 371969 0
Volume of cryoprecipitate transfused (units)
From medical records
Timepoint [7] 371969 0
Within 24 hours post partum
Secondary outcome [8] 371970 0
Volume of platelets transfused (units)
From medical records
Timepoint [8] 371970 0
Within 24 hours post partum
Secondary outcome [9] 371971 0
Percentage of patients requiring hysterectomy
From medical records
Timepoint [9] 371971 0
Within 24 hours post partum
Secondary outcome [10] 371972 0
Percentage of patients requiring intensive care unit (ICU) admission
From medical records
Timepoint [10] 371972 0
Within 24 hours post partum

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Sample size calculations were performed using STATA statistical software. Assuming a baseline rate of 10% transfusions in the control group and a 50% reduction in the intervention group being clinically significant, a sample size of 435 patients per group will have 80% power of producing a statistically significant finding at a 5% significance level.
We plan to analyse 450 patients in each group (approximately 8-10 months of data for each of the pre- and post- groups) to account for missing patient data, which is not expected to be a significant issue.


Our hypothesis is that ROTEM use will reduce the proportion of patients in our pre-defined population who require red cell transfusion.

For our primary outcome, we will perform logistic regression to determine and quantify any association between ROTEM use and red cell transfusion. We will adjust for the demographic and obstetric factors identified as confounders. For patients delivering on the labour ward, we will also adjust for volume of labour ward bleeding. A p-value of less than 0.05 will be considered statistically significant. We will test for interaction between mode of delivery and use of ROTEM, and perform a subgroup analysis if significant interaction is present.

For the secondary outcomes, we will perform logistic regression to examine associations between ROTEM use and the categorical variables (transfusion of other blood products, hysterectomy and ICU admission). We will perform linear regression to examine associations between ROTEM use and the numerical variables (volumes of blood loss and units of blood products transfused).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/02/2018
Date of last participant enrolment
Anticipated
26/07/2019
Actual
26/07/2019
Date of last data collection
Anticipated
26/07/2019
Actual
26/07/2019
Sample size
Target
900
Accrual to date
Final
900
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14097 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 26888 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 303143 0
Hospital
Name [1] 303143 0
Sunshine Hospital
Country [1] 303143 0
Australia
Primary sponsor type
Individual
Name
Dr Yiying (Sally) Tsang
Address
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 303140 0
Individual
Name [1] 303140 0
Dr Georgina Imberger
Address [1] 303140 0
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country [1] 303140 0
Australia
Other collaborator category [1] 280819 0
Individual
Name [1] 280819 0
Dr David Bramley
Address [1] 280819 0
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country [1] 280819 0
Australia
Other collaborator category [2] 280820 0
Individual
Name [2] 280820 0
Dr Elizabeth Hessian
Address [2] 280820 0
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country [2] 280820 0
Australia
Other collaborator category [3] 280821 0
Individual
Name [3] 280821 0
Dr Ade Kurniawan
Address [3] 280821 0
Western Health
Locked Bag 2
Footscray VIC 3011
Country [3] 280821 0
Australia
Other collaborator category [4] 280822 0
Individual
Name [4] 280822 0
Dr Owen Tomasek
Address [4] 280822 0
Austin Health
Studley Road
Heidelberg VIC 3084
Country [4] 280822 0
Australia
Other collaborator category [5] 280823 0
Individual
Name [5] 280823 0
Dr Oliver Daly
Address [5] 280823 0
Department of Obstetrics and Gynaecology
Western Health
PO Box 294
St Albans VIC 3021
Country [5] 280823 0
Australia
Other collaborator category [6] 280824 0
Individual
Name [6] 280824 0
Dr Koen Simon
Address [6] 280824 0
Western Health
PO Box 294
St Albans VIC 3021
Country [6] 280824 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303692 0
Western Health Low Risk Human Research Ethics Panel
Ethics committee address [1] 303692 0
Office for Research
Level 3 Western Centre for Health, Research & Education (CHRE)
Sunshine Hospital
Furlong Road
St Albans VIC 3021
Ethics committee country [1] 303692 0
Australia
Date submitted for ethics approval [1] 303692 0
23/09/2017
Approval date [1] 303692 0
25/10/2017
Ethics approval number [1] 303692 0
QA2017.74

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94510 0
Dr Yiying (Sally) Tsang
Address 94510 0
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country 94510 0
Australia
Phone 94510 0
+61 3 8345 6639
Fax 94510 0
Email 94510 0
y.s.tsang1@gmail.com
Contact person for public queries
Name 94511 0
Dr Yiying (Sally) Tsang
Address 94511 0
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country 94511 0
Australia
Phone 94511 0
+61 3 8345 6639
Fax 94511 0
Email 94511 0
y.s.tsang1@gmail.com
Contact person for scientific queries
Name 94512 0
Dr Yiying (Sally) Tsang
Address 94512 0
Department of Anaesthesia
Western Health
Locked Bag 2
Footscray VIC 3011
Country 94512 0
Australia
Phone 94512 0
+61 3 8345 6639
Fax 94512 0
Email 94512 0
y.s.tsang1@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No current plans have been made for IPD sharing (not applied for on ethics proposal) but willing to consider requests if need/benefit exists


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3872Basic resultsNo 377863-(Uploaded-15-10-2021-10-02-21)-Basic results summary.pdf
4131Plain language summaryNo From abstract: 90 (20%) of patients treated prior... [More Details]
4771Study results articleYes Tsang, Y(S), Kurniawan, AR, Tomasek, O, Hessian, E... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of rotational thromboelastometry-guided transfusion management in patients undergoing surgical intervention for postpartum hemorrhage: An observational study.2021https://dx.doi.org/10.1111/trf.16637
N.B. These documents automatically identified may not have been verified by the study sponsor.