Volume overload

Status: 
Ready to upload
Record number: 
1644
Adverse Occurrence type: 
MPHO Type: 
Estimated frequency: 
Volume overload occurred in 25 (12.7%) patients in the plasma group. The majority of volume overload events occurred within the first 7 days after study product infusion (21/29 [72.4%] in the plasma group and 7/11 [63.6%] in the 4F-PCC group and nine (4.7%) patients in the 4F-PCC group)
Alerting signals, symptoms, evidence of occurrence: 
Fluid overload, pulmonary edema, cardiac failure congestive cardiac failure chronic, and cardiac failure. A large proportion of the patients who developed volume overload had received diuretics (21/25 [84.0%] and seven of nine [77.8%] in the plasma and 4F-PCC groups, respectively), illustrating the fragile fluid balance that these patients need to maintain. This study shows that the use of plasma (vs. 4F-PCC), history of CHF, and history of renal disease appear to be independently predictive of volume overload. The median (range) 4F-PCC dose, volume, and infusion time were 25 (15.5-50.5) IU/kg, 90 (48-230) mL, and 17 (7-288) minutes, respectively. The median (range) plasma dose, volume, and infusion time were 10 (3.9- 17.7) mL/kg, 800 (353-1525) mL, and 120 (22-928) minutes, respectively.
Demonstration of imputability or root cause: 
This study is a post hoc analysis of patient-level data collected from two international, multicenter, Phase IIIb, prospective, active-controlled, open-label, randomized noninferiority trials of patients followed up to Day 51 post infusion of plasma or 4-factor PCC. As such, this analysis is not powered for safety outcomes.
Imputability grade: 
2 Probable
Groups audience: 
Suggest new keywords: 
four-factor PCC
Reference attachment: 
Suggest references: 
Majed A. Refaai,1 Joshua N. Goldstein,2 Martin L. Lee,3 Billie L. Durn,4 Truman J. Milling Jr,5 and Ravi Sarode. Increased risk of volume overload with plasma compared with four-factor prothrombin complex concentrate for urgent vitamin K antagonist reversal.TRANSFUSION 2015;00;00–00 doi:10.1111/trf.13191