Back to resultsRotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial. (REduCe)
Primary Purpose
Cirrhosis, Liver
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
ROTEM
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis, Liver focused on measuring ROTEM, Invasive Procedure, Cirrhosis, Blood Product
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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
Sites / Locations
- Changi General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
ROTEM guided Group
Arm Description
Participants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR)
Participants will receive blood products transfusion based on ROTEM results
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Peri-procedural bleeding complications
1. 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)
Transfusion related adverse events
Adverse events are defined as any side effect occurring within 6 hours of blood product infusion
Hospital Length of stay
Total hospital length of stay (in days)
30-day and 90-day survival
Survival rate at 30-day and 90-day from time of procedure
Thrombotic Complications
Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion
Procedure related complications-other than bleeding
Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed
Full Information
NCT ID
NCT05698134
First Posted
January 15, 2023
Last Updated
January 24, 2023
Sponsor
Changi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05698134
Brief Title
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
Acronym
REduCe
Official Title
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
May 28, 2023 (Anticipated)
Study Completion Date
May 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver
Keywords
ROTEM, Invasive Procedure, Cirrhosis, Blood Product
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Participants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR)
Arm Title
ROTEM guided Group
Arm Type
Experimental
Arm Description
Participants will receive blood products transfusion based on ROTEM results
Intervention Type
Diagnostic Test
Intervention Name(s)
ROTEM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Difference in amount of blood products transfused
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Peri-procedural bleeding complications
Description
1. 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)
Time Frame
24 months
Title
Transfusion related adverse events
Description
Adverse events are defined as any side effect occurring within 6 hours of blood product infusion
Time Frame
24 months
Title
Hospital Length of stay
Description
Total hospital length of stay (in days)
Time Frame
24 months
Title
30-day and 90-day survival
Description
Survival rate at 30-day and 90-day from time of procedure
Time Frame
24 months
Title
Thrombotic Complications
Description
Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion
Time Frame
24 months
Title
Procedure related complications-other than bleeding
Description
Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul Kumar, MBBS
Phone
65 6788 8833
Email
rahul.kumar@singhealth.com.sg
Phone
65 6788 8833
Email
rahul.kumar@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Rahul Kumar, MBBS
First Name & Middle Initial & Last Name & Degree
Chin Kimg Tan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
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