Cirrhosis, LiverREduCeNCT05698134
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
A study testing ROTEM in people with Cirrhosis, Liver, run by Changi General Hospital at 1 site in Singapore.
Trial summary
REDuCe is designed to evaluate the role of ROTEM™ in determining the need and the amount of pre-emptive blood products use in patients with cirrhosis undergoing elective procedures compared to the current standard of care. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- ROTEM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Aug 2021to 28 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Cirrhosis undergoing elective procedure must meet all following criterias.
- Patients undergoing the following elective procedures will be included in the study
- Gastroscopy with endoscopic variceal ligation
- Colonoscopy with polypectomy and endoscopic mucosal resection
- ERCP with sphincterotomy
- Percutaneous liver biopsy
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- Biopsy of other sites (excluding liver)
- Hepatic venous pressure gradient with or without liver biopsy
- Elective Transjugular Intrahepatic Portosystemic Shunt
- Portal Vein embolization
- Trans-arterial chemo-embolization (TACE)
- Thermal ablation of hepatocellular carcinoma
- Large volume paracentesis
- Central venous catheter insertion
- Thoracentesis
- Age: Older than 21 years
- Coagulopathy based on conventional coagulation tests which is defined as
- INR > 1.5 and/or aPTT > 1.5x ULN for PTT and/or
- Platelets < 50,000/mm3/uL
- Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
- Able to give informed consent.
Who cannot join
- Emergency procedures. (defined as life-saving procedures)
- On-going bleeding
- Under 21 years of age
- Inability to obtain informed consent from patients
- Coagulation disorders (other than those relating to liver disease)
- Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)
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- Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)
- Active malignancy except hepatocellular carcinoma
- Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days
- Patients with stage 4 or 5 chronic kidney disease
- Patients receiving renal replacement therapy
- Patients with active sepsis as defined by ACPP-SCCM criteria (21).
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore
Rahul Kumar, MBBS, 65 6788 8833, rahul.kumar@singhealth.com.sg
65 6788 8833, rahul.kumar@singhealth.com.sg
About this study
REDuCe is designed to evaluate the role of ROTEM™ in determining the need and the amount of pre-emptive blood products use in patients with cirrhosis undergoing elective procedures compared to the current standard of care. The secondary aim of this study is to evaluate ROTEM™ parameters in patients with acute decompensation, acute on chronic liver failure and acute liver failure and to co-relate it with the conventional coagulation tests.
Read the detailed description
Patients with cirrhosis who meets eligibility criteria will be divided into two groups
- Those who are undergoing elective procedures will be randomized into 1:1 ratio into either standard of care (institutional transfusion protocol) or ROTEM guided protocol. Baseline ROTEM will be obtained before and after blood product transfusion.
- Those who are not for elective procedures and does not meet criteria for randomization will be entered into data collection for secondary endpoints analysis. These patients will have baseline ROTEM before transfusion and post transfusion ROTEM in those who require blood prodducts transfusion.
- Conditions
- Cirrhosis, Liver
- Being tested
- ROTEM, Standard of care
- Keywords
- ROTEM, Invasive Procedure, Cirrhosis, Blood Product
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMDiagnostic test
ROTEM is a commercially available whole blood Viscoelastic-Haemostatic Assay(VHA) point-of-care, global and dynamic haemostasis assessment tests that measures the viscoelastic changes occurring during the haemostatic process. They provide real-time, comprehensive reflection of the interaction between plasma, blood cells and platelets. It display hypo or hyper-coagulable features in patients with cirrhosis. It is widely used prior to cardiac, obstetric, trauma and liver transplant surgery to assess and correct for coagulation defects.
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Participants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR) Receives: Other: Standard of care |
| ROTEM guided Group | Experimental | Participants will receive blood products transfusion based on ROTEM results Receives: Diagnostic Test: ROTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in amount of blood products transfused
The difference in amount/volume of blood products used(fresh frozen plasma in mls, cryoprecipitate in units and platelets in units) used in patients with cirrhosis undergoing elective procedure.
Measured: 24 months
Secondary outcomes (6)
Peri-procedural bleeding complications
- Peri-procedural bleeding complications (e.g. immediate, and delayed bleeding) defined as overt bleeding or haemoglobin drop requiring transfusion with a target of 8 g/dL.
- Immediate Bleeding (<24 hours of procedure)
- Delayed bleeding (> 24 hours of procedure)
Measured: 24 months
Transfusion related adverse events
Adverse events are defined as any side effect occurring within 6 hours of blood product infusion
Measured: 24 months
Hospital Length of stay
Total hospital length of stay (in days)
Measured: 24 months
30-day and 90-day survival
Survival rate at 30-day and 90-day from time of procedure
Measured: 24 months
Thrombotic Complications
Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion
Measured: 24 months
Procedure related complications-other than bleeding
Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Aug 2021
- Primary completion28 May 2023 (estimated)
- Study completion28 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: First group will receive standard of care based on institutional protocol for blood product transfusion Second group will receive ROTEM guided protocol for blood product transfusion
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698134
- Sponsor's protocol ID
- 2020/3087
- Acronym
- REduCe
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar R, Ng LXL, Wong YJ, Tan CK, Wang LZ, Qiu TY, Wong B, Lin KW, Li JW, Kwek ABE, Ang TL, Gokhle RS, Sivanath TP. Rotational Thromboelastometry Reduces the Need for Preemptive Transfusion in Cirrhosis: A Randomized Controlled Trial (NCT:05698134). J Clin Exp Hepatol. 2025 Jan-Feb;15(1):102409. doi: 10.1016/j.jceh.2024.102409. Epub 2024 Sep 7.
PubMed 39391324
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05698134
- Acronym / sponsor ID
- REduCe / 2020/3087
- Conditions
- Cirrhosis, Liver
- Keywords
- ROTEM, Invasive Procedure, Cirrhosis, Blood Product
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 28 May 2023 (estimated)
- Study completion
- 28 May 2023 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REDuCe is designed to evaluate the role of ROTEM™ in determining the need and the amount of pre-emptive blood products use in patients with cirrhosis undergoing elective procedures compared to the current standard of care. The secondary aim of this study is to evaluate ROTEM™ parameters in patients with acute decompensation, acute on chronic liver failure and acute liver failure and to co-relate it with the conventional coagulation tests.
Detailed description
Patients with cirrhosis who meets eligibility criteria will be divided into two groups
- Those who are undergoing elective procedures will be randomized into 1:1 ratio into either standard of care (institutional transfusion protocol) or ROTEM guided protocol. Baseline ROTEM will be obtained before and after blood product transfusion.
- Those who are not for elective procedures and does not meet criteria for randomization will be entered into data collection for secondary endpoints analysis. These patients will have baseline ROTEM before transfusion and post transfusion ROTEM in those who require blood prodducts transfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: First group will receive standard of care based on institutional protocol for blood product transfusion Second group will receive ROTEM guided protocol for blood product transfusion
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careParticipants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR) |
| ROTEM guided Group | Experimental | Diagnostic Test: ROTEMParticipants will receive blood products transfusion based on ROTEM results |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients with Cirrhosis undergoing elective procedure must meet all following criterias.
- Patients undergoing the following elective procedures will be included in the study
- Age: Older than 21 years
- Coagulopathy based on conventional coagulation tests which is defined as
- Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
Key exclusion criteria (13 listed)
- Emergency procedures. (defined as life-saving procedures)
- On-going bleeding
- Under 21 years of age
- Inability to obtain informed consent from patients
- Coagulation disorders (other than those relating to liver disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEMROTEM is a commercially available whole blood Viscoelastic-Haemostatic Assay(VHA) point-of-care, global and dynamic haemostasis assessment tests that measures the viscoelastic changes occurring during the haemostatic process. They provide real-time, comprehensive reflection of the interaction between plasma, blood cells and platelets. It display hypo or hyper-coagulable features in patients with cirrhosis. It is widely used prior to cardiac, obstetric, trauma and liver transplant surgery to assess and correct for coagulation defects. | Diagnostic test | ROTEM guided Group |
| Standard of careStandard of care | Other | Standard of care |
Primary outcome
Difference in amount of blood products transfused
Time frame: 24 months
The difference in amount/volume of blood products used(fresh frozen plasma in mls, cryoprecipitate in units and platelets in units) used in patients with cirrhosis undergoing elective procedure.
6 secondary outcomes
Peri-procedural bleeding complications
Time frame: 24 months
Transfusion related adverse events
Time frame: 24 months
Hospital Length of stay
Time frame: 24 months
30-day and 90-day survival
Time frame: 24 months
Thrombotic Complications
Time frame: 24 months
Procedure related complications-other than bleeding
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 39391324Kumar R, Ng LXL, Wong YJ, Tan CK, Wang LZ, Qiu TY, Wong B, Lin KW, Li JW, Kwek ABE, Ang TL, Gokhle RS, Sivanath TP. Rotational Thromboelastometry Reduces the Need for Preemptive Transfusion in Cirrhosis: A Randomized Controlled Trial (NCT:05698134). J Clin Exp Hepatol. 2025 Jan-Feb;15(1):102409. doi: 10.1016/j.jceh.2024.102409. Epub 2024 Sep 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROTEM in people with Cirrhosis, Liver, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in amount of blood products transfused (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.