N/A Completed N=68 Randomized Double-blind Diagnostic

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

Cirrhosis · Coagulopathy

Source: ClinicalTrials.gov NCT02457403 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcomePrimary: Intra-operative Blood Loss — 2000; 3000 milliliters

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Intra-operative Blood Loss	2000; 3000	—
SECONDARY Number of Participants With Bleeding Events	1; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02457403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.