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

Not Applicable

Completed

• Conditions: Cirrhosis; Coagulopathy
• Interventions: Device: ROTEM; Other: Conventional Therapy

• Registration Number: NCT02457403
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Primary Completion: 2018-11
• Study Completion: 2018-11-30
• Results First Submitted: 2020-03-12
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-31
• Last Update Submitted: 2020-12-31
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	ROTEM	Transfusion guided by conventional labs
ROTEM	ROTEM	Transfusion guided by ROTEM during OLT
Conventional	Conventional Therapy	Transfusion guided by conventional labs
ROTEM	Conventional Therapy	Transfusion guided by ROTEM during OLT

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Bleeding Events	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).	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).