Phase 3
N=57
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Blood Coagulation Disorders · Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02637427 ↗Enrolled (actual)
57
Serious AEs
8.8%
Results posted
Aug 2021
Primary outcome: Primary: Change in Hemoglobin Level — -0.6; -0.4 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fresh frozen plasma transfusion (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin Level |
-0.6; -0.4 | — |
| SECONDARY Number of Red Blood Cell Transfusions |
0; 0 | — |
| SECONDARY Number of Participants With Transfusion Associated Cardiac Overload (TACO) |
0; 2 | — |
| SECONDARY Number of Participants With Transfusion Related Acute Lung Injury (TRALI). |
0; 0 | — |
| SECONDARY Number of Participants With Major Bleed |
1; 0 | — |
| SECONDARY Change in International Normalized Ratio (INR) Level Post Procedure |
-0.24; 0 | — |
| SECONDARY Change in INR Level Day 1 |
-0.22; -0.03 | — |
| SECONDARY Change in INR Level Day 2 |
-0.09; 0 | — |
| SECONDARY Mortality (Number of Participants) |
1; 0 | — |
| SECONDARY Number of Participants With Infection |
0; 1; 2; 1 | — |
| SECONDARY Number of Participants With ICU Admission |
1; 2 | — |
Summary
The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.
Eligibility Criteria
Inclusion Criteria
- INR level between 1.50 and 2.50 inclusive
- undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology
Exclusion Criteria
- undergoing a surgical procedure in the operating room;
- active bleeding;
- undergoing a procedure involving or proximal to the central nervous system or spinal cord;
- cardiac catheterization,
- using 4 factor plasma concentrates
- using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR;
- platelet count less than 50,000/ul,
- congenital coagulation disorders;
- acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder;
- women who are pregnant and;
- unwillingness to consider blood transfusion.
Data sourced from ClinicalTrials.gov (NCT02637427). 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.