ANZCTR - Registration

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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

22/08/2022

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]

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

Coagulopathy

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Surgery

Other surgery

Blood

Clotting disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients in the ROTEM arm will receive blood product prophylaxis according to ROTEM cut-offs based on recommendations from surgical and trauma guidelines:
If EXTEM CT > 80 seconds, and no cryoprecipitate indicated: Transfuse FFP 10-15ml/kg
If EXTEM CT > 80 seconds and cryoprecipitate also indicated: Transfuse 1 unit FFP
If EXTEM A5 <35mm and FIBTEM A5 = 9mm: Transfuse 1-2 bags platelets
If EXTEM A5 <35mm and FIBTEM A5 < 9mm: Transfuse one dose cryoprecipitate

Intervention code [1]

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]

Proportion of procedures requiring prophylactic transfusion
(assessed through electronic blood product ordering and delivery records)

Timepoint [1]

Prior to procedure (day 0)

Primary outcome [2]

Peri-procedural bleeding complications (e.g. immediate, and delayed bleeding)
(assessed through electronic medical records and patient survey)

Timepoint [2]

day 7

Primary outcome [3]

Amount of pre-procedural blood products given (FFP/platelets/cryoprecipitate)

Timepoint [3]

Day 0 (prior to procedure)
(assessed through electronic medical records)

Secondary outcome [1]

Transfusion-related side effects (e.g. volume overload, transfusion reactions, transfusion-related lung injury)
(assessed through patient survey and electronic hospital records)

Timepoint [1]

Day 0

Secondary outcome [2]

Procedure-related complications other than bleeding (e.g. thrombosis, infection)
(assessed through patient survey and electronic hospital records)

Timepoint [2]

Day 0, 7 and 28

Secondary outcome [3]

Hospital length of stay

Timepoint [3]

Day 0, 7, 28
(assessed through patient survey and electronic hospital records)

Secondary outcome [4]

Survival

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Recruiting

Date of first participant enrolment

Anticipated

1/08/2020

Actual

26/02/2021

Date of last participant enrolment

Anticipated

30/11/2023

Actual

Date of last data collection

Anticipated

31/12/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Box Hill Hospital - Box Hill

Recruitment hospital [4]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [5]

Dandenong Hospital - Dandenong

Recruitment hospital [6]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [7]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

3004 - Prahran

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

3128 - Box Hill

Recruitment postcode(s) [4]

3065 - Fitzroy

Recruitment postcode(s) [5]

3175 - Dandenong

Recruitment postcode(s) [6]

6009 - Nedlands

Recruitment postcode(s) [7]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Health

Address [1]

55 Commercial Rd
Melbourne, VIC, 3004

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Blood Authority

Address [2]

Level 2, 243 Northbourne Avenue
Lyneham ACT 2602
Australia

Country [2]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Rd 
Melbourne, VIC, 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/04/2019

Approval date [1]

19/06/2019

Ethics approval number [1]

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

Dr Ammar Majeed

Address

Department of Gastroenterology
Alfred Health
99 Commercial Rd
Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 90762223

Fax

[email protected]

Contact person for public queries

Name

Natasha Janko

Address

Department of Gastroenterology
Alfred Health
99 Commercial Rd
Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 9076 2223

Fax

[email protected]

Contact person for scientific queries

Name

Natasha Janko

Address

Department of Gastroenterology
Alfred Health
99 Commercial Rd
Melbourne, VIC, 3004

Country

Australia

Phone

+61 3 9076 2223

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5715	Ethical approval					377338-(Uploaded-11-10-2019-12-15-36)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Rotational ThromboElastometry-guided blood component administration versus standard of care in patients with Cirrhosis and coagulopathy undergoing Invasive ProcEdures (RECIPE): study protocol for a randomised controlled trial.	2023	https://dx.doi.org/10.1186/s13063-023-07552-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically