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

The Ohio State University

Status: Completed

Conditions: Coagulopathy; Cirrhosis

Treatments: Device: ROTEM; Other: Conventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02457403

2014H0487

Details and patient eligibility

About

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).

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

ROTEM

Experimental group

Description:

Transfusion guided by ROTEM during OLT

Treatment:

Device: ROTEM

Other: Conventional Therapy

Conventional

Active Comparator group

Description:

Transfusion guided by conventional labs

Treatment:

Device: ROTEM

Other: Conventional Therapy