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Trial registered on ANZCTR


Registration number
ACTRN12619000644167
Ethics application status
Approved
Date submitted
7/04/2019
Date registered
30/04/2019
Date last updated
15/11/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rotational Thromboelastometry (ROTEM)-guided blood product in patients with cirrhosis undergoing invasive
procedures
Scientific title
Randomised controlled trial (RCT) examining the effect of ROTEM-guided blood component administration versus standard of care on blood component transfusion requirements and complications in patients with cirrhosis and coagulopathy undergoing invasive procedures
Secondary ID [1] 297892 0
None
Universal Trial Number (UTN)
U1111-1231-2485
Trial acronym
RECIPE (RotEm-guided blood product in patients with Cirrhosis undergoing Invasive ProcEdures)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Liver cirrhosis 312271 0
Coagulopathy 312272 0
Condition category
Condition code
Oral and Gastrointestinal 310819 310819 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 310820 310820 0 0
Other surgery
Blood 310821 310821 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ROTEM analysis will be conducted and blood components if needed, will be given prior to the procedure. ROTEM cut offs will be based on trauma guidelines:
Platelets will only be given if EXTEM MCF less than 45mm with FIBTEM MCF greater than or equal to 10mm irrespective of platelet count.
FFP will only be given if EXTEM CT > 80 seconds or INTEM CT >240 seconds irrespective of INR/PT/APTT
Intervention code [1] 314120 0
Diagnosis / Prognosis
Comparator / control treatment
Standard of care
Use of INR and platelet count to guide FFP and platelet transfusion prior to invasive procedures
Control group
Active

Outcomes
Primary outcome [1] 319660 0
Proportion of procedures requiring prophylactic transfusion
(assessed through electronic blood product ordering and delivery records)

Timepoint [1] 319660 0
Prior to procedure (day 0)
Primary outcome [2] 319661 0
Peri-procedural bleeding complications (e.g. immediate, and delayed bleeding)
(assessed through electronic medical records and patient survey)
Timepoint [2] 319661 0
day 7
Primary outcome [3] 319880 0
Amount of pre-procedural blood product (FFP/platelets) given
Timepoint [3] 319880 0
Day 0 (prior to procedure)
(assessed through electronic medical records)
Secondary outcome [1] 369067 0
Transfusion-related side effects (e.g. volume overload, transfusion reactions, transfusion-related lung injury)
(assessed through patient survey and electronic hospital records)
Timepoint [1] 369067 0
Day 0
Secondary outcome [2] 369068 0
Procedure-related complications other than bleeding (e.g. thrombosis, infection)
(assessed through patient survey and electronic hospital records)
Timepoint [2] 369068 0
Day 0, 7 and 28
Secondary outcome [3] 369069 0
Hospital length of stay
Timepoint [3] 369069 0
Day 0, 7, 28
(assessed through patient survey and electronic hospital records)
Secondary outcome [4] 369070 0
Survival
Timepoint [4] 369070 0
28 day
(assessed through electronic hospital records and patient reports)

Eligibility
Key inclusion criteria
-Males and females aged 18 years or older
-Cirrhosis
-Planned for an invasive procedure
-Coagulopathic on the basis of conventional coagulation tests
-Able to give informed consent

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Persons under 18 years of age
-Inability or unwillingness to give informed consent
-Coagulation disorders (other than those relating to liver disease)
-Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixiban).
-Patients on anti-platelet aggregation agents other than aspirin (eg. clopidogrel, ticagrelor)
-Patients in whom it is difficult to obtain blood samples due to venous access difficulties
-Active malignancy
-Patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior
- Patients with stage 4 or 5 chronic kidney disease
-Patients receiving renal replacement therapy
-Patients with active sepsis

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed with participants undergoing computer-based randomisation. The person assessing the participants eligibility for the trial will be unaware of which arm the patient will be randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Adaptive randomisation will be performed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size is still being calculated.

Statistical analysis
All statistical analyses will be performed using SPSS/STATA.
Continuous variables will be presented as medians and inter-quartile ranges (IQR), and analysed with Mann-Whitney test for skewed distributions. Binomial data will be presented as proportions or percentage, and compared using Chi-square or Fisher’s exact test. A p-value less than 0.05 is considered statistically significant in a two-sided test. Multivariate analysis is planned with linear regression (number of blood product units transfused) for continuous outcomes and logistic regression (for binary outcome transfused or not) for categorical data.

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment hospital [1] 13559 0
The Alfred - Prahran
Recruitment hospital [2] 13560 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26204 0
3004 - Prahran
Recruitment postcode(s) [2] 26205 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302414 0
Hospital
Name [1] 302414 0
Alfred Health
Address [1] 302414 0
55 Commercial Rd
Melbourne, VIC, 3004
Country [1] 302414 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Department of Gastroenterology
Alfred Hospital
99 Commercial Rd
Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 302310 0
None
Name [1] 302310 0
N/A
Address [1] 302310 0
N/A
Country [1] 302310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303083 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303083 0
55 Commercial Rd
Melbourne, VIC, 3004
Ethics committee country [1] 303083 0
Australia
Date submitted for ethics approval [1] 303083 0
29/04/2019
Approval date [1] 303083 0
19/06/2019
Ethics approval number [1] 303083 0
HREC/53920/Alfred-2019

Summary
Brief summary
The aim of this project is to examine the role of a ‘global’ coagulation assay called Rotational Thromboelastometry (ROTEM) in the guidance of prophylactic blood product in patients with liver cirrhosis undergoing invasive procedures.

Currently available laboratory tests (such as platelet count, International Normalised Ratio (INR) and activated partial thromboplastin time (aPTT)) are suboptimal for the assessment of bleeding risk in patients with chronic liver disease. These tests may overestimate the risk of bleeding, and their use may result in unnecessary transfusion of blood and coagulation products, exposing the patients to risk of serious adverse events and potentially overuse of scarce blood products.

During the past few years, ‘global’ coagulation tests such as ROTEM have been developed to provide an overall measurement of the clotting system. These point of care tests provide quick results and have been used to assess coagulation and better guide blood product transfusion in a number of surgical and trauma multi-transfusion settings. However, the value of these global tests in predicting bleeding outcomes and guiding blood component transfusion in liver disease has not been well studied.

We plan a multi-centre randomised-controlled trial (RCT) examining ROTEM-based decisions to guide FFP and platelet use in patients with cirrhosis undergoing invasive procedures. We hypothesise that using ROTEM to guide blood product delivery in this setting, will lead to reduced usage of blood products whilst maintaining optimal clinical outcomes.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92410 0
Dr Ammar Majeed
Address 92410 0
Department of Gastroenterology
Alfred Health
99 Commercial Rd
Melbourne, VIC, 3004
Country 92410 0
Australia
Phone 92410 0
+61 3 90762223
Fax 92410 0
Email 92410 0
A.Majeed@alfred.org.au
Contact person for public queries
Name 92411 0
Dr Natasha Janko
Address 92411 0
Department of Gastroenterology
Alfred Health
99 Commercial Rd
Melbourne, VIC, 3004
Country 92411 0
Australia
Phone 92411 0
+61 3 9076 2223
Fax 92411 0
Email 92411 0
n.janko@alfred.org.au
Contact person for scientific queries
Name 92412 0
Dr Natasha Janko
Address 92412 0
Department of Gastroenterology
Alfred Health
99 Commercial Rd
Melbourne, VIC, 3004
Country 92412 0
Australia
Phone 92412 0
+61 3 9076 2223
Fax 92412 0
Email 92412 0
n.janko@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5715 0
Ethical approval
Citation [1] 5715 0
Link [1] 5715 0
Email [1] 5715 0
Other [1] 5715 0
Summary results
No Results