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

Cirrhosis Clinical Trial

— SCARLET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457403
• Other study ID #: 2014H0487
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 30, 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cirrhosis
• Coagulopathy
• Fibrosis
• Hemostatic Disorders
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).