Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
NCT ID: NCT05698134
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
74 participants
INTERVENTIONAL
2021-08-01
2023-05-28
Brief Summary
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Detailed Description
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1. 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.
2. 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
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
DOUBLE
Study Groups
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Standard of care
Participants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR)
Standard of care
Standard of care
ROTEM guided Group
Participants will receive blood products transfusion based on ROTEM results
ROTEM
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.
Interventions
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ROTEM
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 care
Standard of care
Eligibility Criteria
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Inclusion Criteria
1. Patients undergoing the following elective procedures will be included in the study
1. Gastroscopy with endoscopic variceal ligation
2. Colonoscopy with polypectomy and endoscopic mucosal resection
3. ERCP with sphincterotomy
4. Percutaneous liver biopsy
5. Biopsy of other sites (excluding liver)
6. Hepatic venous pressure gradient with or without liver biopsy
7. Elective Transjugular Intrahepatic Portosystemic Shunt
8. Portal Vein embolization
9. Trans-arterial chemo-embolization (TACE)
10. Thermal ablation of hepatocellular carcinoma
11. Large volume paracentesis
12. Central venous catheter insertion
13. Thoracentesis
2. Age: Older than 21 years
3. Coagulopathy based on conventional coagulation tests which is defined as
1. INR \> 1.5 and/or aPTT \> 1.5x ULN for PTT and/or
2. Platelets \< 50,000/mm3/uL
4. Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
5. Able to give informed consent.
Exclusion Criteria
2. On-going bleeding
3. Under 21 years of age
4. Inability to obtain informed consent from patients
5. Coagulation disorders (other than those relating to liver disease)
6. Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)
7. Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)
8. Active malignancy except hepatocellular carcinoma
9. Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days
10. Patients with stage 4 or 5 chronic kidney disease
11. Patients receiving renal replacement therapy
12. Patients with active sepsis as defined by ACPP-SCCM criteria (21).
13. Pregnant Women
21 Years
90 Years
ALL
No
Sponsors
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Changi General Hospital
OTHER
Responsible Party
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Locations
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Changi General Hospital
Singapore, , Singapore
Countries
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Facility Contacts
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Role: backup
References
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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.
Other Identifiers
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2020/3087
Identifier Type: -
Identifier Source: org_study_id
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