Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.

NCT05698134 | Unknown DMC

• 1 other identifier: 2020/3087
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cirrhosis, Liver

Keywords

ROTEM; Invasive Procedure; Cirrhosis; Blood Product

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (6)

• Peri-procedural bleeding complications

  24 months

• Transfusion related adverse events

  24 months

• Hospital Length of stay

  24 months

• 30-day and 90-day survival

  24 months

• Thrombotic Complications

  24 months

Study Arms (2)

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)

Other: Standard of care

ROTEM guided Group

EXPERIMENTAL

Participants will receive blood products transfusion based on ROTEM results

Diagnostic Test: ROTEM

Interventions

ROTEM DIAGNOSTIC_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.

ROTEM guided Group

Standard of care OTHER

Standard of care

Standard of care

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 39391324 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: January 26, 2023
• Study Start: August 1, 2021
• Primary Completion: May 28, 2023
• Study Completion: May 28, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)