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Adjusted versus actual body weight dosing of 4-factor prothrombin complex concentrate in obese patients with
Keaton S Smetana1, Rachel Ziemba2, Casey C May3
1Department of Pharmacy, The Ohio State University Wexner Medical Center, 410 W. 10th Ave, Doan Hall Room 368, Columbus, OH, 43210, USA. Keaton.Smetana@osumc.edu.
Insights
Dosing four-factor prothrombin complex concentrate (4F-PCC) using adjusted body weight in obese patients leads to lower reversal rates. Actual body weight dosing is recommended for obese patients when using the 100 kg cap.
Area of Science:
- Pharmacology
- Critical Care Medicine
- Hematology
Background:
- The standard dosing for 4-factor prothrombin complex concentrate (4F-PCC) is weight-based, with a 100 kg cap.
- Obese patients represent a unique challenge for 4F-PCC dosing due to a lack of specific guidelines.
- Previous studies have not adequately addressed optimal 4F-PCC dosing strategies in obesity.
Purpose of the Study:
- To compare the efficacy of 4F-PCC dosing based on actual body weight (ActBW) versus adjusted body weight (AdjBW) in obese patients.
- To determine the optimal dosing strategy for 4F-PCC in patients with a body mass index (BMI) of 30 kg/m² or higher.
- To evaluate the rate of coagulopathy reversal in obese patients receiving 4F-PCC.
Main Methods:
- A retrospective analysis of 78 obese patients (BMI ≥ 30 kg/m²) who received 4F-PCC for warfarin-associated bleeding reversal.
- Patients were divided into two groups: those dosed using AdjBW and those dosed using ActBW.
- The primary outcome was the percentage of patients achieving a post-treatment INR < 1.4 (neurologic indications) or < 1.5 (other indications).
Main Results:
- The AdjBW group had a significantly lower rate of achieving the goal INR compared to the ActBW group (36% vs. 68%; p=0.006).
- The median dose of 4F-PCC was lower in the AdjBW group (2120 units) compared to the ActBW group (2500 units; p=0.02).
- While not statistically significant, a higher proportion of patients in the ActBW group had intracranial hemorrhage (54% vs. 32%).
Conclusions:
- Dosing 4F-PCC using adjusted body weight in obese patients resulted in a significantly lower rate of coagulopathy reversal.
- Actual body weight dosing should be considered for obese patients when utilizing the 100 kg dose cap as per package insert recommendations.
- Further prospective studies are warranted to confirm optimal 4F-PCC dosing in obese populations.
Abstract:
The package insert of 4-factor prothrombin complex concentrate (4F-PCC) contains specific dosing recommendations stating to determine the patients dose based on their INR and weight, capping the weight at 100 kg. However, the mean body mass index (BMI) in the 4F-PCC U.S. approval study was 27 kg/m2, and there is a lack of literature identifying the ideal dosing strategy in obesity. We conducted a retrospective analysis of obese patients (BMI ≥ 30 kg/m2) who received 4F-PCC for warfarin associated emergent bleeding reversal. Treatment groups were those that received 4F-PCC on adjusted body weight (AdjBW) and those on actual body weight (ActBW). The primary outcome was the percent of patients achieving coagulopathy reversal, defined as a post-treatment INR < 1.4 for neurologic indications and < 1.5 for all others. A total of 78 obese patients were included (28 AdjBW and 50 ActBW). Baseline INR (3.1 vs. 2.8; p = 0.052) and BMI (33.6 vs. 33.6 kg/m2) were similar between groups. Achievement of goal INR was significantly lower in the AdjBW group (36% vs. 68%; p = 0.006). A majority of patients had intracranial hemorrhage (32% vs. 54%; p = 0.06), and the median dose of 4F-PCC was lower in the AdjBW group (2120 vs. 2500 units; p = 0.02). Dosing 4F-PCC using adjusted body weight in obese patients resulted in a significantly lower rate of coagulopathy reversal. ActBW should be used to dose 4F-PCC in obese patients when the 100 kg dose cap is utilized per the package insert recommendations.
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