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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Cirrhosis, Coagulopathy

Intervention / Treatment
-----------------
* Device: ROTEM
* Other: Conventional Therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROTEM<br>Transfusion guided by ROTEM during OLT | Device: ROTEM<br>* 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.<br>Other: Conventional Therapy<br>* 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.<br>|
| Active Comparator: Conventional<br>Transfusion guided by conventional labs | Device: ROTEM<br>* 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.<br>Other: Conventional Therapy<br>* 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.<br>|

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). |