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Trial registered on ANZCTR


Registration number
ACTRN12617001069347
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
24/07/2017
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
ROTEM® and platelet function in pre-eclamptic obstetric patients
Scientific title
ROTEM® and platelet function in pre-eclamptic obstetric patients: A prospective observational study on labour ward inpatients.
Secondary ID [1] 292416 0
None
Universal Trial Number (UTN)
U1111-1199-1145
Trial acronym
RPM
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Pre-eclampsia 304002 0
Condition category
Condition code
Reproductive Health and Childbirth 303336 303336 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Only patients with a diagnosis of pre-eclampsia will be included and blood tests in the form of ROTEM NATEM, Multiplate and the standard coagulation profile will be processed at the point of routine blood tests being done.
Intervention code [1] 298587 0
Diagnosis / Prognosis
Comparator / control treatment
A substudy of a cohort of 20 patients will be included from patients with uncomplicated pregnancies who are undergoing elective Caesareans
Control group
Active

Outcomes
Primary outcome [1] 302724 0
Extent of platelet dysfunction in pre-eclampsia will be assessed via Multiplate results
Timepoint [1] 302724 0
Peripartum upon diagnosis of pre-eclampsia and presentation for obstetric review.
Primary outcome [2] 303865 0
Platelet function will be assessed by the Multiplate test in both the substudy cohort and the study population.
Timepoint [2] 303865 0
Pre-elective Caesarean
Secondary outcome [1] 336830 0
Volume of blood loss (assessed via visual estimation)
Timepoint [1] 336830 0
Within 24 hours of delivery (whether it be a vaginal delivery or Caesarean section)
Secondary outcome [2] 337088 0
Incidence of primary postpartum haemorrhage (if this volume is >500mL for a vaginal delivery or >1000mL for a Caesarean section this would be defined as a primary postpartum haemorrage) (assessed via visual estimation)
Timepoint [2] 337088 0
Within 24 hours of delivery of the baby.

Eligibility
Key inclusion criteria
Key inclusion criteria:
• Potential study participants will be identified as per antenatal booking lists initially for the provision of information leaflets
• Patients must have clinically diagnosed pre-eclampsia (the whole spectrum of the disease, including HELLP (haemolysis, elevated liver enzymes, low platelets) syndrome)
• Potential participants will include inpatients of the labour ward which will include patients not yet in established labour, as well as parturients.
• These patients will be included into the study upon presentation to the labour ward at the point of requiring intravenous (IV) cannulation and/or venepuncture, either for medical management, for the insertion of a labour epidural, or for induction or augmentation of labour.
• Pregnant patients of any gestation will be included, as long as they have the diagnosis of pre-eclampsia confirmed or are treated for suspected pre-eclampsia
• Patients requiring communication via an interpreter, mild to moderate mental illness; mild intellectual impairment; Aboriginal and Torres Strait Island patients will be coincidentally included.
Key inclusion criteria for substudy of 20 patients:
* Patients undergoing an elective Caesarean section
* Patients with uncomplicated pregnancies and no history of coagulation abnormalities
Minimum age
18 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• All labour ward inpatients without a diagnosis of pre-eclampsia
• Age < 18, age > 55, SEVERE* cognitive impairment, SEVERE mental illness, moderate to SEVERE intellectual disability.
• Sampling time: ROTEM® samples must be processed within four hours and some of these samples may be missed if samples taken after-hours are unable to be processed by the limited pathology staff rostered on for that period. Processing of other specimens will take priority during the after-hours period, which may render some ROTEM® samples non-viable due to the time-constraints and these will be excluded from the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical advice has been provided by the Statistics Department of the Queensland Institute of Medical Research. The proposed study period will be 12 months and based on estimates, there will be approximately 100-150 patients potentially included in the study, at which point we will review our data to assess the need for further extension of this study. There were 131 pre-eclamptic patients who presented to RBWH in 2014. Demographic and baseline data will be presented as frequencies/percent for categorical data or means/standard deviations for continuous data. Continuous data will be analysed using analysis of variance (ANOVA), and the chi square test will be applied to categorical data. Correlation between Multiplate® values, standard coagulation profiles, ROTEM® NATEM values and platelet counts will be assessed via Pearson’s correlation. Factors that affect the strength of the correlation will be assessed using general linear models. Data relating to pregnancy and neonatal outcome will be collected as this may be affected by anaesthetic technique as well as any coagulation defect resulting from platelet dysfunction.

Subcategories of pre-eclampsia (mild PET, HELLP, severe PET) will be analysed if sufficient numbers are recruited from each group, but this will be dependent on the distribution of pre-eclamptic patients recruited during the study period. The method of statistical analysis will be determined once recruitment is complete.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8564 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16668 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296965 0
Other Collaborative groups
Name [1] 296965 0
Australian and New Zealand College of Anaesthetists
Address [1] 296965 0
630 St Kilda Rd, Melbourne, VIC 3004
Country [1] 296965 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston, QLD 4006
Country
Australia
Secondary sponsor category [1] 295972 0
University
Name [1] 295972 0
University of Queensland
Address [1] 295972 0
St Lucia, QLD 4072
Country [1] 295972 0
Australia
Secondary sponsor category [2] 295973 0
Government body
Name [2] 295973 0
National Blood Authority
Address [2] 295973 0
Level 2, 243 Northbourne Avenue, Lyneham ACT 2602
Country [2] 295973 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298170 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 298170 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4006
Ethics committee country [1] 298170 0
Australia
Date submitted for ethics approval [1] 298170 0
22/06/2017
Approval date [1] 298170 0
27/06/2017
Ethics approval number [1] 298170 0
HREC/15/QRBW/97

Summary
Brief summary
We intend to undertake this research project on ROTEM®, which is a rapid and specific blood clotting test which has been recently introduced to analyse clotting. This is a rapid test in that results can be obtained within 10 minutes, compared with 30 to 60 minutes for the current standard clotting test. It is specific in that it further defines parameters to assist in deciding what blood products need to be given in the event of bleeding. We will also analyse platelet function using a test called Multiplate®.

The purpose of this study is to better understand the type and extent of clotting issues that are potentially seen with the pregnancy-related condition known as pre-eclampsia. You will not receive any direct benefit from participating in this study, but the knowledge gained from this research will help us to improve the management of major bleeding in pregnant patients.

If a patient develops pre-eclampsia (uncommon condition) throughout the course of their pregnancy and if they agree to participate, then we will obtain a 7.5mL blood sample either through their IV drip or cannula when it is placed, or when they have blood tests done. This blood sample will be used to process for Multiplate® results, ROTEM® clotting test and the standard clotting test. If the patient has further routine blood tests performed, we will perform matched samples until the pre-eclampsia resolves. If a patient's pregnancy is uncomplicated and if they do not require an IV drip or any blood tests during their labour, then they will not be included in the study.

As a substudy, we intend to recruit 20 women undergoing an elective Caesarean, who have experienced uncomplicated pregnancies and have no history of coagulation disorders, to establish a normal range against which the results of our main study cohort will be compared.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76214 0
Dr Julie Lee
Address 76214 0
Department of Anaesthesia and Perioperative Medicine,
Level 4 Ned Hanlon Building,
Butterfield St,
The Royal Brisbane and Women's Hospital,
Herston QLD 4006
Country 76214 0
Australia
Phone 76214 0
+617 3646 5453
Fax 76214 0
Email 76214 0
julielee01@gmail.com
Contact person for public queries
Name 76215 0
Dr Julie Lee
Address 76215 0
Department of Anaesthesia and Perioperative Medicine,
Level 4 Ned Hanlon Building,
Butterfield St,
The Royal Brisbane and Women's Hospital,
Herston QLD 4006
Country 76215 0
Australia
Phone 76215 0
+617 3646 5453
Fax 76215 0
Email 76215 0
julielee01@gmail.com
Contact person for scientific queries
Name 76216 0
Dr Claire Manning
Address 76216 0
Department of Anaesthesia and Perioperative Medicine,
Level 4 Ned Hanlon Building,
Butterfield St,
The Royal Brisbane and Women's Hospital,
Herston QLD 4006
Country 76216 0
Australia
Phone 76216 0
+617 3646 5453
Fax 76216 0
Email 76216 0
clairemmanning@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable