Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy (SCARLET)

A Prospective, Randomized Clinical Trial Comparing Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy: Rotational Thromboelastography (ROTEM) Versus Conventional Therapy

A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Coagulopathy
• Intervention / Treatment: Device: ROTEM; Other: Conventional Therapy

Detailed Description

Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18 and older, admitted to the hospital
• Patients who have clinically documented cirrhosis
• Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000)
• Patients undergoing an endoscopic procedure or neurosurgical procedure

Exclusion Criteria:

• Patients must not be pregnant
• Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)
• Patients must not have an active infection (per PI discretion)
• Patients must not have any known hemostatic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ROTEM; Transfusion guided by ROTEM during OLT	Device: ROTEM; Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.; Other: Conventional Therapy; Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.
ACTIVE_COMPARATOR: Conventional; Transfusion guided by conventional labs	Device: ROTEM; Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.; Other: Conventional Therapy; Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative Blood Loss	Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.	Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Bleeding Events	Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months).	Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Adam J Hanje, MD, Assistant Professor-Clinical

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (ESTIMATE): May 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Liver Diseases; Hemorrhagic Disorders; Fibrosis; Hemostatic Disorders; Blood Coagulation Disorders; Liver Cirrhosis
• Other Study ID Numbers: 2014H0487