Audit and Evaluation of the Effect of Fresh Frozen Plasma and Adjunct Pharmacological Agents (Vitamin K1, Prothrombin Complex Concentrate, Tranexamic Acid, and Recombinant Factor VIIa) on Pre- and Post- Transfusion INR in Patients with Coagulopathy: A Prospective Study.

BACKGROUND: Coagulopathy is frequently encountered in patients with liver disease, trauma, anticoagulant therapy, and perioperative bleeding. Fresh Frozen Plasma (FFP) is widely used to correct coagulation abnormalities associated with elevated International Normalized Ratio (INR). However, plasma alone may not always provide optimal correction. Adjunct pharmacological agents such as vitamin K1 (phytonadione), prothrombin complex concentrate (PCC), tranexamic acid (TXA), and Recombinant Factor VIIa (rFVIIa) are increasingly used to improve coagulation outcomes. OBJECTIVE: To evaluate the effectiveness of FFP transfusion and the role of adjunct pharmacological therapy in correcting elevated INR values. MATERIALS AND METHODS: A prospective observational study was conducted in a tertiary care teaching hospital over a period of 1 year. Adult patients (≥18 years) receiving FFP transfusion for elevated INR (>1.5) due to bleeding or prophylaxis before invasive procedures were included (n = 120). Pre-transfusion INR values were compared with post-transfusion INR measured within 6-12 hours. Data on concomitant administration of vitamin K1, PCC, TXA, and rFVIIa were recorded. Exclusion criteria included congenital coagulation disorders, incomplete records, and out-of-hospital transfusions. Statistical analysis was performed using paired t-test and ANOVA for subgroup comparisons (P < 0.05 is significant). RESULTS: The mean pre-transfusion INR was 3.15 ± 1.20, decreasing significantly to 1.96 ± 0.82 post-transfusion (P < 0.001). Subgroup analysis showed greater INR reduction with adjuncts: FFP + PCC (1.78 ± 0.60), FFP + vitamin K1 (1.32 ± 0.52), FFP + rFVIIa (1.65 ± 0.55), and FFP + TXA (1.05 ± 0.48) compared to FFP alone (0.80 ± 0.45; P < 0.01). Minor transfusion reactions occurred in 3.3% of patients. CONCLUSION: FFP significantly reduces INR in coagulopathy, with adjuncts like vitamin K1 and PCC enhancing correction. Rational integration of blood components and pharmacology optimizes outcomes and transfusion practices.