CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
ROTEM +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02457403
NCT02457403N/ACompleted
CompareCT.gov

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

Ohio State University·interventional·Posted May 29, 2015·Updated Jan 22, 2021

In Brief

A clinical study evaluating ROTEM and Conventional Therapy for Cirrhosis and Coagulopathy. Completed, enrolled 68 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis, Coagulopathy
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 29, 2015
Enrollment StartMay 1, 2015
Primary CompletionNov 1, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.1 years ago

Interventions

ROTEMdevice

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 Therapyother

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.