N/A
N=68
Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy
Cirrhosis · Coagulopathy
Bottom Line
View on ClinicalTrials.gov: NCT02457403 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Intra-operative Blood Loss — 2000; 3000 milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ROTEM (Device); Conventional Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-operative Blood Loss |
2000; 3000 | — |
| SECONDARY Number of Participants With Bleeding Events |
1; 0 | — |
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).
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
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.