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

NCT ID: NCT02457403

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-11-30

Brief Summary

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).

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.

Conditions

Cirrhosis; Coagulopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

ROTEM

Transfusion guided by ROTEM during OLT

Group Type: EXPERIMENTAL

ROTEM

Intervention Type: DEVICE

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.

Conventional Therapy

Intervention Type: OTHER

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.

Conventional

Transfusion guided by conventional labs

Group Type: ACTIVE_COMPARATOR

ROTEM

Intervention Type: DEVICE

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.

Conventional Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

James Hanje

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam J Hanje, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor-Clinical

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2014H0487

Identifier Type: -

Identifier Source: org_study_id