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

Cirrhosis, Liver Clinical Trial

— REduCe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698134
• Other study ID #: 2020/3087
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 28, 2023

Study information

• Verified date: January 2023
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

Patients with cirrhosis who meets eligibility criteria will be divided into two groups

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: May 28, 2023
• Est. primary completion date: May 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

Patients with Cirrhosis undergoing elective procedure must meet all following criterias.

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:

1. Emergency procedures. (defined as life-saving procedures)

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Diagnostic Test:
• 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.

Other:
• Standard of care
Standard of care

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	24 months
Secondary	Transfusion related adverse events	Adverse events are defined as any side effect occurring within 6 hours of blood product infusion	24 months
Secondary	Hospital Length of stay	Total hospital length of stay (in days)	24 months
Secondary	30-day and 90-day survival	Survival rate at 30-day and 90-day from time of procedure	24 months
Secondary	Thrombotic Complications	Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion	24 months
Secondary	Procedure related complications-other than bleeding	Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed	24 months