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

NCT02457403 | Completed Results

• 1 other identifier: 2014H0487
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cirrhosis; Coagulopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (2)

ROTEM

EXPERIMENTAL

Transfusion guided by ROTEM during OLT

Device: ROTEM; Other: Conventional Therapy

Conventional

ACTIVE COMPARATOR

Transfusion guided by conventional labs

Device: ROTEM; Other: Conventional Therapy

Interventions

ROTEM 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; ROTEM

Conventional Therapy 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; ROTEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

MeSH Terms

Conditions

Fibrosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: A James Hanje
• Organization: The Ohio State University

james.hanje@osumc.edu

614 293 6255

Study Officials

• Adam J Hanje, MD

  Assistant Professor-Clinical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 29, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 30, 2018
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12