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REDuCe is designed to evaluate the role of ROTEMâ„¢ 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 ROTEMâ„¢ 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.
Patients with cirrhosis who meets eligibility criteria will be divided into two groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| ROTEM guided Group | Experimental | Participants will receive blood products transfusion based on ROTEM results |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 24 months |
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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
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.
Able to give informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39391324 | Derived | 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. |
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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
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|
| Standard of care | Other | Standard of care |
|
| Transfusion related adverse events |
Adverse events are defined as any side effect occurring within 6 hours of blood product infusion |
| 24 months |
| Hospital Length of stay | Total hospital length of stay (in days) | 24 months |
| 30-day and 90-day survival | Survival rate at 30-day and 90-day from time of procedure | 24 months |
| Thrombotic Complications | Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion | 24 months |
| Procedure related complications-other than bleeding | Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed | 24 months |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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