Comparison of Low- Versus High-Dose Four-Factor Prothrombin Complex Concentrate (4F-PCC) for Factor Xa Inhibitor–Associated Bleeding: A Retrospective Study

2020 ◽  
pp. 088506662091670 ◽  
Author(s):  
H Andrew Wilsey ◽  
Abby M. Bailey ◽  
Aric Schadler ◽  
George A. Davis ◽  
Melissa Nestor ◽  
...  

Background: Although andexanet alfa was recently approved as a specific reversal agent for apixaban and rivaroxaban, some providers still elect to administer 4-factor prothrombin complex concentrate (4F-PCC) instead, due to concerns surrounding efficacy, thrombotic risk, administration logistics, availability, and cost. Previous studies have described success with 4F-PCC doses ranging from 25 to 35 U/kg, with some guidelines recommending 50 U/kg. Objectives: The purpose of this study was to compare hemostasis between patients receiving low- (20-34 U/kg) versus high-dose (35-50 U/kg) 4F-PCC for the urgent reversal of apixaban and rivaroxaban. Patients/Methods: We performed a retrospective cohort study at a level one trauma center and comprehensive stroke center between January 2015 and December 2018. Main exclusion criteria included patients receiving less than 20 U/kg or if postreversal imaging were unavailable. Outcomes assessed included hemostasis for critical bleeding associated with apixaban or rivaroxaban and postoperative bleeding for reversal for emergent procedures. Results: The low-dose strategy was administered to n = 57 (57.6%) patients at a mean dose of 26.6 U/kg. The high-dose strategy was used in n = 42 (42.4%) patients at a mean dose of 47.6 U/kg. There was no difference in hemostasis by dosing strategy (75.4% vs 78.6%, P = .715) or hospital mortality (19.3% vs 35.7%, P = .067). No difference was found for secondary end points, including thrombotic events (5.3% vs 2.4%, P = .635) and hospital length of stay (11.3 vs 12.5 days, P = .070). Conclusions: Our comparison addresses a gap in the literature surrounding optimal dosing and supports a similar efficacy profile between dosing low- versus high-dose treatment.

Author(s):  
Spencer Davis ◽  
Stephanie Chauv ◽  
Abby W. Hickman ◽  
Dave S. Collingridge ◽  
Sara Kjerengtroen ◽  
...  

Author(s):  
RIO RAHMADI ◽  
NUR RASYID ◽  
PONCO BIROWO

Objective: This study was designed to compare the efficacy and safety of the supine and prone positions in percutaneous nephrolithotomies (PCNLs) used for the treatment of kidney stones in Indonesian patients. Methods: This was a single-blinded randomized controlled trial of those patients undergoing PCNLs from February to May of 2018. There were 19 subjects in the supine group and 19 in the prone group for a total of 38 study subjects. The study outcomes that were compared included the operative time, hospital length of stay (LOS), stone-free rate, blood loss, conversion to open surgery, blood transfusion, and complications. These outcomes were evaluated using the Student’s t test and the chi-squared test. Results: There were no significant differences in the patient demographics or stone locations between the two groups. Additionally, the medians of the operative times, LOSs, blood losses, and blood transfusions were not statistically different. There was a higher stone-free rate in the supine group than in the prone group (70.0% vs. 47.4%, respectively, p = 0.151). More subjects were transfused in the supine group (30.0%) than in the prone group (15.8%), but this difference was not statistically significant (p = 0.292). The only complications were infundibular lacerations, which occurred in 20% of the subjects in the supine group and 15.8% of the subjects in the prone group (p = 0.732). Conclusion: This study showed that the supine and prone positions for PCNLs had similar efficacy and safety outcomes.


2017 ◽  
Vol 38 (06) ◽  
pp. 726-736 ◽  
Author(s):  
Lanting Fuh ◽  
Jonathan Sin ◽  
Joshua Goldstein ◽  
Bryan Hayes

AbstractIn patients with acute intracerebral hemorrhage (ICH), one of the major concerns is ongoing bleeding or ICH expansion. Anticoagulated patients are at higher risk of ongoing expansion and worse outcome. It may be that rapid anticoagulation reversal can reduce the risk of expansion and improve clinical outcome. For those taking coumarins, the best available evidence suggests that intravenous vitamin K combined with four-factor prothrombin complex concentrate (4F-PCC) is the most rapid and effective regimen to restore hemostasis. For those on dabigatran, the highest quality data available for reversal are for idarucizumab, although it is not yet clear whether patients derive clinical benefit from this reversal. In the absence or failure of idarucizumab, activated prothrombin complex concentrate (aPCC) is recommended. For those on factor Xa inhibitors, the ideal reversal agent is not clear. Many providers use 4F-PCC or aPCC, but more specific agents are in clinical trials and may soon be available. In addition, the half-lives of the non–vitamin K antagonists are relatively short compared with warfarin, and so some patients may not have a clinically relevant coagulopathy at the time of presentation. Overall, the optimal reversal agent, when one is required, is a function of which anticoagulant the patient is taking.


2022 ◽  
Vol 8 ◽  
Author(s):  
Zhimin Liang ◽  
Xiaofan Deng ◽  
Lingli Li ◽  
Jing Wang

Aim: To compare the arthroscopy vs. arthrotomy for the treatment of native knee septic arthritis.Methods: Electronic databases of PubMed, Embase and Cochrane Library were searched for eligible studies. Retrospective comparative studies comparing arthroscopy or arthrotomy for patients with septic arthritis of the native knee were eligible for this review. The primary outcome was recurrence of infection after first procedure. The secondary outcomes included hospital length of stay, operative time, range of motion of the involved knee after surgery, overall complications and mortality rate,Results: Thirteen trials were included in this study. There were a total of 2,162 septic arthritis knees treated with arthroscopic debridement and irrigation, and 1,889 septic arthritis knees treated with open debridement and irrigation. Arthroscopy and arthrotomy management of the knee septic arthritis showed comparable rate of reinfection (OR = 0.85; 95% CI, 0.57–1.27; P = 0.44). No significant difference was observed in hospital length of stay, operative time and mortality rate between arthroscopy and arthrotomy management group, while arthroscopy treatment was associated with significantly higher knee range of motion and lower complication rate when compared with arthrotomy treatment.Conclusion: Arthroscopy and arthrotomy showed similar efficacy in infection eradication in the treatment of native septic knee. However, arthroscopy treatment was associated with better postoperative functional recovery and lower complication rate.


JAMA ◽  
2021 ◽  
Author(s):  
Igor H. Murai ◽  
Alan L. Fernandes ◽  
Lucas P. Sales ◽  
Ana J. Pinto ◽  
Karla F. Goessler ◽  
...  

Author(s):  
Arturo G. Torres ◽  
Edward McGough

Fast-track cardiac care (FTCC) encompasses the entire spectrum of perioperative care for the cardiothoracic surgical patient. From the preoperative assessment to postoperative care, the main goal is to expedite recovery while minimizing the inherent risks associated with cardiac surgery. The practice of prolonged mechanical ventilation due to high-dose narcotic anesthesia has evolved to early protocolized extubation pathways facilitated by multimodal anesthesia. The goal of the postoperative care phase is focused on reducing or completely bypassing the intensive care unit and ultimately decreasing hospital length of stay. Yet, here is where FTCC seems unable to achieve its goals due to multifactorial barriers. An integral part of successful FTCC is constant reevaluation of the patient through each of the perioperative phases (pre-, intra-, and postoperatively).


2018 ◽  
Vol 24 (6) ◽  
pp. 908-913 ◽  
Author(s):  
Lara M. Groetzinger ◽  
Taylor J. Miller ◽  
Ryan M. Rivosecchi ◽  
Roy E. Smith ◽  
Mark T. Gladwin ◽  
...  

Background: Little data exist on the use of direct oral anticoagulant (DOAC) factor Xa inhibitors for submassive pulmonary embolism (PE) after catheter-directed thrombolysis (CDT). The objective of this evaluation was to determine whether the transition from parenteral anticoagulation to DOACs for submassive PE after CDT would decrease hospital length of stay (LOS) compared to warfarin. Methods: A retrospective review of patients diagnosed with submassive PE who underwent CDT was conducted from January 1, 2012, to February 28, 2017. Hospital LOS and major and minor bleeding events were recorded during hospitalization and at 90 days. Results: Sixty-two patients met the inclusion criteria, 36 in warfarin group and 26 in the DOAC group. Overall, patients receiving rivaroxaban or apixaban had a shorter median hospital LOS compared to warfarin (4.0 vs 6.1 days, P = .002). In the multivariate regression analysis, administration of DOAC was an independent predictor of decreased hospital LOS, β: −2.1, 95% confidence interval (−3.5 to −0.7). Conclusion: Among patients with submassive PE, initiation of a DOAC shortly after CDT may result in a decreased hospital LOS compared to parenterally bridged warfarin.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4636-4636
Author(s):  
Justina Ofori Frimpong ◽  
Rebecca Tombleson ◽  
Melissa Alsina ◽  
Jamie Shapiro ◽  
Jongphil Kim ◽  
...  

Abstract Background: Chemotherapy administration to obese patients poses significant challenges due to the potential for augmented toxicities. There are limited guidelines and literature available on the dosing of high-dose therapy followed by autologous hematopoietic cell transplantation (HCT) in obese patients and dosing practices vary widely. We conducted a single-center, retrospective cohort study to compare outcomes and toxicities after high-dose melphalan followed by autologous HCT among non-obese (body mass index [BMI] < 30 kg/m2), obese (BMI 30-34.9 kg/m2), and severely obese (BMI ≥ 35 kg/m2) multiple myeloma patients. Patients and Methods: A total of 462 consecutive patients transplanted between January 2004 and December 2011 were included. Patients who had received a tandem transplant and those with the diagnosis of amyloidosis were excluded. The primary endpoint of the study was to compare the incidence of non-relapse mortality (NRM) and overall survival (OS) rates across all three cohorts. Secondary endpoints included progression-free survival (PFS), incidence of relapse, hospital length of stay, hospital readmission rates, engraftment and grade 3 and 4 non-hematologic toxicities. Results: All three cohorts had similar baseline characteristics except for age ≤ 65 years (yrs) (severely obese 85.3%, obese 66.7%, non-obese 63%; p = 0.001), and the use of adjusted body weight for melphalan dosing (severely obese 41.2%, obese 25.7%, non-obese 4.5%; p < 0.0001). Across all three cohorts, there were no significant differences in NRM, relapse/progression, OS, PFS, engraftment, response to transplant, hospital length of stay, 30-day readmission rates, grade 3 to 4 nausea, vomiting, enteritis, or renal toxicity. In univariate analyses, Durie-Salmon Stage (DSS) 3 was the only independent predictor of inferior OS. DSS 3 and ≥ 2 lines of therapy were significant predictors of inferior PFS. In a multivariate analysis, DSS 3 (hazard ratio [HR] 2.28, 95% confidence interval [CI]: 1.01-5.13, p = 0.05), age > 65 yrs (HR 2.13, 95%CI: 1.19-3.82, p = 0.01), serum creatinine (Cr) ≥ 1 mg/dL were associated with higher NRM, whereas actual weight (AW) dosing was associated with decreased risk of NRM (HR 0.38, 95%CI: 0.19-0.72, p = 0.003). Additionally, age ≤ 65 yrs (HR 1.32, 95%CI: 1.03-1.71, p = 0.03), baseline serum Cr ≤ 1.5 mg/dL were associated with increased risk of relapse/progression, whereas disease status ≥ partial response prior to HCT (HR 0.71, 95%CI: 0.54-0.94, p = 0.02) and BMI ≥ 35 kg/m2 (HR 0.62, 95%CI: 0.44-0.87, p = 0.01) were associated with decreased risk of relapse/progression. In a subgroup analysis evaluating only patients with AW dosing of melphalan, febrile neutropenia was more common in non-obese patients compared to obese and severely obese patients (71.4% versus 56.4% and 62.5%, respectively; p = 0.03). Conclusions: High-dose melphalan and autologous HCT can be performed safely in obese myeloma patients and BMI of ≥ 30 kg/m2 does not appear to be associated with adverse transplant outcomes. Further analysis is needed to evaluate the effect of dose adjustments on outcomes. Disclosures Alsina: Onyx: Speakers Bureau; Millenium Pharmaceuticals: Research Funding; Novartis: Research Funding; Signal Genetics: Consultancy; Onyx: Consultancy. Nishihori:Signal Genetics: Research Funding; Novartis: Research Funding.


2017 ◽  
Vol 24 (6) ◽  
pp. 998-1004 ◽  
Author(s):  
Alireza Jahangirifard ◽  
Zargham Hossein Ahmadi ◽  
Farah Naghashzadeh ◽  
Babak Sharif-Kashani ◽  
Farin Rashid-Farokhi ◽  
...  

The present study is the premier clinical attempt to scrutinize the practicability of prophylactic fibrinogen infusion in patients undergoing heart transplantation (HT). A total of 67 consecutive patients who had undergone HT between January 2012 and December 2014 were assessed. After exclusion of some patients, 23 patients were given preoperative 2 g fibrinogen concentrate over a period of 15 minutes after the termination of cardiopulmonary bypass pump and complete reversal of heparin, and 30 patients were not given. Some laboratories were measured before general anesthesia and at 6 and 24 hours after surgery. In addition, major adverse events were also evaluated during hospitalization. The mean age of the patients was 39.5 ± 11.4 years, with a predominance of male sex (77.4%). All laboratories at baseline were comparable between groups. The length of hospital stay was longer in the control group compared to the fibrinogen group (20 [16-22] vs 16 [12-19] days; P = .005). There was a trend for patients in the fibrinogen group to have more acute kidney injury (AKI) after surgery (10% vs 30.4%) and less reoperation for bleeding (20% vs 8.7%). The amount of postoperative bleeding was significantly higher in the control group compared to the fibrinogen group ( P < .001). The number of packed red blood cell transfused during 24 hours after surgery was significantly lower in the fibrinogen group ( P < .001). The transfusion of fibrinogen in patients undergoing HT may be associated with reductions in postoperative bleeding, the number of packed red blood cells, and hospital length of stay; however, it may enhance postoperative AKI.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20035-e20035
Author(s):  
Darragh O'Donoghue ◽  
Huong Truong ◽  
Heidi Diann Finnes ◽  
Jennifer McDonald ◽  
Stephen M. Ansell ◽  
...  

e20035 Background: HDMTX is a vital treatment of lymphoma secondary to central nervous system penetrance. MTX is nephrotoxic and may cause acute kidney injury (AKI). AKI results in delayed MTX elimination, increased hospital length of stay (LOS) and intensive care unit (ICU) stays. Our aim was to characterise the complications and associated 48-hour MTX levels in lymphoma patients undergoing HDMTX. Methods: A retrospective review of the electronic medical record was conducted to identify lymphoma patients who received HDMTX from 1/1/2002 to 12/31/18. We assessed the incidence of AKI using AKIN criteria, ICU admission, and LOS across 48 hour MTX levels per the table. Results: 2704 cycles of HDMTX were identified. The mean age was 64 years, 54% were male and 72.2% received high dose (≥8g/m2). A significant increase in AKI severity (p < 0.0001) and LOS (p < 0.01) occurred with increasing 48 hour MTX levels, (p < 0.001, Table). All 7 patients requiring dialysis had MTX levels > 10. ROC curve analysis for AKI grade ≥ 2 demonstrated a 48 hour MTX level threshold of 1.28 (AUC 0.79) with relative risk of 7.6 (95% CI 5.3-11) and odds ratio of 8.8 (95% CI 5.9-13.1). A significant increase occurred in LOS across escalating 48 hour MTX level subgroups (p < 0.01, Table). A significant rise in ICU admissions occurred with increasing MTX levels ( < 0.01% for MTX < 2 compared to 15% with MTX > 5). Conclusions: Complications of HDMTX are significantly increased with elevated 48 hour MTX levels, particularly with levels > 1 μmol/L. [Table: see text]


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