Abstract P415: Is Hemostatic Efficacy of Four Factor Prothrombin Complex Concentrate Similar in Intracerebral Hemorrhage Patients Receiving Warfarin vs Non-Vitamin K Anticoagulants?

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Gregory Pon ◽  
Brittany Pelsue ◽  
Xu Zhang ◽  
Brian Gulbis ◽  
Sujan T Reddy ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Multivariable Analysis ◽  
Chi Square ◽  
Significant Difference ◽  
Forward Stepwise ◽  
Multivariable Regression ◽  
Baseline Characteristics ◽  
Hemostatic Efficacy

Introduction: Four Factor Prothrombin Complex Concentrate (4F-PCC) is indicated for reversal of warfarin-induced coagulopathy. In small cohort studies, 4F-PCC has similar hemostatic efficacy rates reversing non-vitamin K anticoagulants (NOACs). There are no comparison studies evaluating 4F-PCC for the reversal of warfarin versus NOACs in the setting of intracerebral hemorrhage (ICH). Methods: A multicenter retrospective cohort study was conducted between 2013-2020 at a comprehensive stroke system in ICH patients who received 4F-PCC for the reversal of warfarin or a NOAC. Patients were included if they were adults with an acute ICH, anticoagulant regimen of warfarin (INR 1.3 or greater) or NOAC, and 2 head CT scans within 24 hours to determine hemostatic efficacy. Hemostatic efficacy was evaluated by the Sarode scale. The chi square and t-test were used as appropriate for demographic and clinical data, with multivariable regression analysis conducted in a forward stepwise manner, retaining variables with significance less than 0.05. Results: One hundred fifty-seven patients were included (baseline characteristics in Table 1). There was no statistically significant difference in effective hemostasis observed between warfarin and NOAC patients (83% vs 75%, p=0.33). Similarly, multivariable analysis did not demonstrate a significant difference in effective hemostasis (OR 0.55, 95% CI: 0.2-1.3, p=0.2). However, due to wide 95% confidence intervals, we cannot exclude a key treatment effect from PCC. After controlling for baseline characteristics, patients treated with NOACs had 53% lower odds of a good clinical outcome compared to those treated with warfarin (Figure 1; OR 0.47, 95% CI: 0.2-1.3, p=0.13). Conclusions: In conclusion, there was no statistically significant difference in hemostatic efficacy or clinical outcomes between warfarin and NOAC patients following reversal with 4F-PCC.

Abstract WP304: Prothrombin Complex Concentrate Rapidly Reverses Coagulopathy but does not Alter Mortality in Warfarin Intracerebral Hemorrhage

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Xuemei Cai ◽  
Susannah Orzell ◽  
Sarah Suh ◽  
Linda Bresette ◽  
Farzaneh Sorond ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Vitamin K ◽  
Conventional Therapy ◽  
Prothrombin Complex Concentrate ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Thromboembolic Complication ◽  
Complication Rates ◽  
Significant Difference ◽  
Fresh Frozen

INTRODUCTION: Warfarin-associated intracerebral hemorrhage (wICH) remains the most lethal form of iatrogenic stroke. Conventional therapy with fresh frozen plasma (FFP) and intravenous vitamin K takes up to 30 hrs to normalize the international normalized ratio (INR). Prothrombin complex concentrate (PCC) does not require cross-match and is fast acting. We hypothesized that PCC can rapidly reverse coagulopathy and reduce mortality in wICH. Methods: We identified 130 consecutive adult wICH patients over five years from a prospectively collected database. 33 patients were excluded for death or withdrawal of care within 48 hours of admission and 8 patients were excluded for antecedent head trauma, leaving 89 patients for analysis. Forty patients received FFP and vitamin K (conventional therapy) and 49 received PCC in addition to conventional therapy. We compared 6-month mortality, time to INR normalization, quantity of FFP transfused, and thromboembolic complication rates between the two groups. We used logistic regression to adjust for important confounders. Results: PCC-treated and conventional therapy patients had similar distributions of age, sex, co-morbidities, ICH location, initial blood pressure and INR. PCC-treated patients had a higher incidence of intraventicular hemorrhage (IVH) (67% vs 33%). PCC-treated patients required less FFP (mean 6.8 units vs 3.3 units, p<0.0001) and had faster time to INR normalization (mean 3.8 hrs vs 9.8 hrs, p<0.0001). Incidence of ICH expansion was low in both groups. There was no difference in the incidence of deep venous thrombosis and pulmonary embolism (p=0.236) or troponin elevation (p=0.573). There was no significant difference in 6-month mortality (p=0.437) after adjusting for age, ICH location, ICH volume, and presence of IVH. Conclusions: PCC use in wICH was associated with shorter time to INR normalization and reduced FFP transfusion but was not associated with 6-month mortality in this cohort. There was no difference in thromboembolic complication rates between PCC-treated and FFP and vitamin K treated patients. Prospective trials of PCC are necessary to determine if its use can improve morbidity and mortality in wICH and to identify potential subgroups of wICH patients who may benefit from PCC.

scholarly journals Reversal of Oral Anticoagulants for Intracerebral Hemorrhage Patients: Best Strategies

2017 ◽  
Vol 38 (06) ◽  
pp. 726-736 ◽  
Author(s):  
Lanting Fuh ◽  
Jonathan Sin ◽  
Joshua Goldstein ◽  
Bryan Hayes
Keyword(s):  
Intracerebral Hemorrhage ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
Quality Data ◽  
Reversal Agent ◽  
Intravenous Vitamin ◽  
Time Of Presentation

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.

Rapid warfarin reversal: a 3-factor prothrombin complex concentrate and recombinant factor VIIa cocktail for intracerebral hemorrhage

2012 ◽  
Vol 116 (3) ◽  
pp. 491-497 ◽  
Author(s):  
Ravi Sarode ◽  
Karén Matevosyan ◽  
Ramesh Bhagat ◽  
Cynthia Rutherford ◽  
Christopher Madden ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Factor Viia ◽  
Standard Of Care ◽  
Factor Vii ◽  
Plasma Therapy ◽  
The Us ◽  
Thrombotic Complications ◽  
Warfarin Reversal

Object Intracerebral hemorrhage (ICH) is the most serious bleeding complication of vitamin K antagonist (VKA) therapy, carrying a high mortality. Rapid reversal of VKA in ICH is critical. Plasma therapy, the standard of care in the US, is not optimal. The ideal prothrombin complex concentrate (PCC) containing all vitamin K–dependent factors (VKDFs) is not available in the US. Therefore, the authors developed a Trauma Coumadin Protocol (TCP) consisting of a 3-factor PCC available in the US (which contains insufficient factor VII [FVII]) with a low-dose recombinant FVIIa to rapidly reverse VKA. Methods Forty-six patients treated with the TCP were retrospectively analyzed. Fourteen patients had pre- and post-TCP plasma samples collected to assess their VKDF increment. Eleven patients had measurable intraparenchymal hematomas, which were evaluated for expansion. Results The mean pre- and post-TCP international normalized ratios (INRs) were 3.4 (median 2.9) and 1.0 (median 0.9), respectively. Once corrected, INR was maintained at < 1.3 during a patient's hospital stay. The pre-TCP median values of FII, FVII, FIX, and FX were 28%, 21%, 45%, and 20%, respectively; post-TCP median values increased to 144%, 417%, 102%, and 143%, respectively. Four of the 11 patients with measurable intraparenchymal hemorrhage had expansion at 24 hours after TCP. One patient probably (8 hours post-TCP) and 1 patient possibly (3 days post-TCP) had thrombotic complications. Conclusions The TCP was very effective in rapidly reversing VKA-associated coagulopathy; however, this protocol should be used cautiously in patients at high risk for thrombosis.

scholarly journals 759: Fixed-Dose Prothrombin Complex Concentrate in Vitamin K Antagonist-Related Intracerebral Hemorrhage

2021 ◽  
Vol 50 (1) ◽  
pp. 373-373
Author(s):  
Caroline Kruszecki ◽  
Danielle Mabrey ◽  
Kim Haldeman ◽  
Lindsey Dailey ◽  
Elizabeth Scanlon
Keyword(s):  
Intracerebral Hemorrhage ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Vitamin K Antagonist ◽  
Fixed Dose

scholarly journals ASXL1/SRSF2 Co-Mutated Acute Myeloid Leukemia (AML): A Rare but Distinct Subpopulation with Dismal Outcomes

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2598-2598
Author(s):  
Daniel R. Richardson ◽  
David M Swoboda ◽  
Anastasia Ivanova ◽  
Steven M Johnson ◽  
Jonathan Galeotti ◽  
...  
Keyword(s):  
Research Funding ◽  
Multivariable Analysis ◽  
Prior History ◽  
Treatment Intensity ◽  
Cell Transplant ◽  
Myeloid Neoplasm ◽  
Significant Difference ◽  
History Of ◽  
Baseline Characteristics

Background: Advances in the understanding of the genetic determinants of AML and the widespread use of next-generation sequencing (NGS) have led to the refinement of prognostically distinct molecular subgroups. Mutations in ASXL1 and SRSF2, which are common in myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPNs), rarely co-occur in patients (pts) with AML. The largest reported cohort (n=15) of ASXL1/SRSF2 co-mutated AML had no long-term survivors (Papaemmanuil et al. NEJM 2016). It remains unknown how clinical factors such as prior history of a myeloid neoplasm or intensity of treatment influence outcomes. We sought to assess the clinical characteristics and analyze outcomes in a larger cohort of pts with ASXL1/SRSF2 co-mutated AML. We hypothesized that this profile may be a genomic footprint of prior myeloid neoplasia. Methods: We conducted a multi-institutional retrospective analysis of newly diagnosed adult AML pts with both ASXL1 and SRSF2 mutations at the University of North Carolina and at Moffitt Cancer Center from 2011-2018. NGS was performed on DNA using the Illumina TruSight Myeloid 54-gene sequencing panel. The primary endpoint was overall survival (OS) defined as time from diagnosis of AML to death. Pts were stratified by secondary AML (s-AML), defined as having a documented history of MDS/MPN. Secondary outcomes included rates of complete remission (CR) and CR with incomplete hematologic recovery (CRi). Multivariable analysis was performed with baseline characteristics. Results: Forty-six pts were identified and included. The median age of pts was 72 years (range 42 - 85). Sixty-seven percent (28/42) had normal cytogenetics; 88% (37/42) were intermediate risk cytogenetics by current ELN guidelines. Sixty-one percent (n=28) were classified as having s-AML. One pt had therapy-related AML without preexisting MDS/MPN and was therefore not included in s-AML. The Figure illustrates co-existing mutations and individual responses to upfront therapy stratified by s-AML and non-s-AML. The median number of mutations was 5 (range 2 - 7). The most common co-occurring mutations were TET2 (52%), RUNX1 (35%), IDH2 (15%), and STAG2 (15%). Median OS was 7.0 months (m) (CI 5.3, 15.4). Median OS for pts with s-AML (n=28) and non-s-AML (n=18) was 6.1 and 15.4 m (p=0.05), respectively. There was no significant difference in median OS between s-AML and non-s-AML on multivariable analysis (hazard ratio (HR) = 2.56, p=0.07). Median OS did not differ by age (Age <65 years v. older, p=0.54), total # of mutations (≥ 5 v. less, p=0.73), or etiology of s-AML (MDS v. MPN, p=0.66). Twenty-two (47%) pts received upfront intensive induction chemotherapy (IC), 17 (37%) received hypomethylating agents (HMAs), and 7 pts (15%) received no AML-directed chemotherapy. Median OS did not significantly differ between pts receiving upfront IC and HMAs (15.3 v. 7.04 m, p=0.21). Among non-s-AML pts, median OS was longer in those receiving IC (n=10) versus HMAs (n=7) (15.4 v. 3.5 m, p=0.01). Among all pts receiving IC, median OS was longer in non-s-AML pts (n=10) versus s-AML pts (n=12) (15.4 v. 5.9 m, p=0.01). Median OS did not differ by treatment intensity for s-AML pts (IC v. HMA: 5.9 v. 9.9 m, p=0.38). Six pts underwent allogeneic hematopoietic cell transplant (HCT) with a median OS NR (median follow-up 15.6 m). Overall rate of CR/CRi was 35% and was similar between pts receiving IC and HMAs (45% v. 21%, p=0.29). Among pts with non-s-AML, CR/CRi rates with IC and HMAs were 70% and 29%, respectively (p=0.11). Among pts with s-AML, CR/CRi rates with IC and HMAs were 42% and 20%, respectively (p=0.38). On multivariable analysis of baseline characteristics, only ECOG performance status (PS) was significantly associated with OS (HR 2.25, p=0.01). ECOG PS remained significant (HR 2.65, p=0.03) after adjusting for HCT and treatment intensity. Conclusions: ASXL1/SRSF2 co-mutated AML represents a rare but distinct genotype with most pts having pre-existing myeloid neoplasms and associated co-mutations commonly seen in MDS/MPNs. OS is dismal regardless of age, number of mutations, treatment intensity, or prior history of myeloid neoplasm. HCT may mitigate these poor outcomes and lead to long-term survival. This represents the largest reported cohort to date of pts with ASXL1/SRSF2 co-mutated AML. Further study is warranted to inform risk stratification and prognosis of pts with ASXL1/SRSF2-mutated AML. Disclosures Foster: Bellicum Pharmaceuticals, Inc: Research Funding; Daiichi Sankyo: Consultancy; MacroGenics: Research Funding; Celgene: Research Funding. Coombs:Octopharma: Honoraria; Pharmacyclics: Honoraria; Medscape: Honoraria; Abbvie: Consultancy; Loxo: Honoraria; Cowen & Co.: Consultancy; Dedham Group: Consultancy; H3 Biomedicine: Honoraria; Covance: Consultancy. Sallman:Celyad: Membership on an entity's Board of Directors or advisory committees. Zeidner:Agios: Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Daiichi Sankyo: Honoraria; Tolero: Honoraria, Research Funding; Pfizer: Honoraria; AsystBio Laboratories: Consultancy; Merck: Research Funding; Takeda: Research Funding; AbbVie: Honoraria.

Prothrombin Complex Concentrate for Intracerebral Hemorrhage Secondary to Vitamin K Deficiency Bleeding in a 6-Week-Old Child

2015 ◽  
Vol 167 (6) ◽  
pp. 1443-1444 ◽  
Author(s):  
Megan A. Rech ◽  
Lindsay Wittekindt ◽  
Samantha D. Friedman ◽  
Kendall Kling ◽  
David Ubogy
Keyword(s):  
Intracerebral Hemorrhage ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Vitamin K Deficiency ◽  
Vitamin K Deficiency Bleeding ◽  
K Deficiency

Admitting Service and Outcome for Small Bowel Obstruction

2021 ◽  
pp. 000313482110540
Author(s):  
Christopher Thacker ◽  
Claire Lauer ◽  
Kathleen Nealon ◽  
Charles Walker ◽  
Matthew Factor
Keyword(s):  
Small Bowel ◽  
Small Bowel Obstruction ◽  
Bowel Obstruction ◽  
Multivariable Analysis ◽  
Admission Diagnosis ◽  
Chi Square ◽  
Surgical Services ◽  
Multivariable Regression ◽  
Student’S T ◽  
The Impact

Introduction Small bowel obstruction (SBO) is a common admission diagnosis. Prior research has shown improved length of stay and time to operation for SBO patients on surgical services (SS) compared to medical services (MS). This study evaluates the impact of admitting service on readmission and mortality. Methods A 12-year retrospective cohort study of patients ≥18 years old, admitted with SBO to either a MS or SS within one health care system was performed. Clinicodemographic characteristics and admission details were extracted and reviewed. Statistical analyses performed included the Student’s t-test, chi-square, and multivariable regression. Results The study included 7921 patients, of which 3862 (48.8%) were admitted to a SS. No significant clinicodemographic differences existed between the groups except SS patients were more likely to have cancer (23.3% vs 15.2%, P < .0001) and to be within a 30-day post-operative period (9.4% vs 1.8%, P < .0001). On multivariable analysis, admission to a SS was associated with a decreased admission mortality (OR .70), 30-day mortality (OR .42), and 180-day mortality (OR .42). 30-day readmissions (OR .54) and 180-day readmission (OR .43) were also significantly decreased for SS patients. In patients requiring a procedure during admission, there was significantly decreased admission mortality (OR .684), 30-day mortality (OR .470), 180-day mortality (OR .431), 30-day readmission (OR .63), and 180-day readmission (OR .50). Conclusion In patients with SBO, admission to a SS confers decreased odds of readmission and mortality compared to MS. Future studies are needed to understand the management decisions potentially underlying these differences. These findings may help better define admission pathways and improve outcomes.

scholarly journals Intracerebral hemorrhage: who gets tested for methamphetamine use and why might it matter?

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Sahar Osman ◽  
Zhu Zhu ◽  
Mark Farag ◽  
Leonid Groysman ◽  
Cyrus Dastur ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Racial Bias ◽  
External Ventricular Drain ◽  
Multivariable Analysis ◽  
Urine Drug Screen ◽  
Methamphetamine Use ◽  
Significant Difference ◽  
Emerging Risk ◽  
History Of ◽  
History Of Use

Abstract Background Methamphetamine use is an emerging risk factor for intracerebral hemorrhage (ICH). The aim of this study was to investigate the use of urine drug screen (UDS) for identifying methamphetamine-associated ICH. Methods This is a retrospective, single-center study of consecutive patients hospitalized with spontaneous ICH from January 2013 to December 2017. Patients were divided into groups based on presence of UDS. The characteristics of patients with and without UDS were compared. Factors associated with getting UDS were explored using multivariable analyses. Results Five hundred ninety-six patients with ICH were included. UDS was performed in 357 (60%), and positive for methamphetamine in 44 (12.3%). In contrast, only 19 of the 357 patients (5.3%) had a documented history of methamphetamine use. Multivariable analysis demonstrated that patients screened with UDS were more likely to be younger than 45 (OR, 2.24; 95% CI, 0.26–0.78; p = 0.004), male (OR, 1.65; 95% CI, 0.44–0.84; p = 0.003), smokers (OR, 1.74; 95% CI, 1.09–2.77; p <  0.001), with history of methamphetamine use (OR, 10.48; 95% CI, 2.48–44.34; p <  0.001), without diabetes (OR 1.47; 95% CI, 0.471–0.975; p = 0.036), not on anticoagulant (OR, 2.20; 95% CI, 0.26–0.78; p = 0.004), with National Institutes of Health Stroke Scale (NIHSS) > 4 (OR, 1.92; 95%CI, 1.34–2.75; p <  0.001), or require external ventricular drain (EVD) (OR, 1.63; 95%CI, 1.07–2.47; p = 0.021. There was no significant difference in race (p = 0.319). Reported history of methamphetamine use was the strongest predictor of obtaining a UDS (OR,10.48). Five percent of patients without UDS admitted history of use. Conclusion UDS identified 12.3% of ICH patients with methamphetamine use as compared to 5.3% per documented history of drug use. There was no racial bias in ordering UDS. However, it was more often ordered in younger, male, smokers, with history of methamphetamine use, without diabetes or anticoagulant use.

Impact of Age on Short-term Outcomes After Lumbar Fusion

Neurosurgery ◽  
2015 ◽  
Vol 77 (3) ◽  
pp. 347-354 ◽  
Author(s):  
Mohamad Bydon ◽  
Nicholas B. Abt ◽  
Rafael De la Garza-Ramos ◽  
Israel O. Olorundare ◽  
Kelly McGovern ◽  
...  
Keyword(s):  
Lumbar Fusion ◽  
Multivariable Analysis ◽  
The Elderly ◽  
Complication Rates ◽  
Improvement Program ◽  
Younger Patients ◽  
Age Cohorts ◽  
Significant Difference ◽  
Age Cohort ◽  
Multivariable Regression

Abstract BACKGROUND: The safety and efficacy of spinal fusion in the elderly population remains uncertain with conflicting data. OBJECTIVE: To determine if elderly patients undergoing instrumented lumbar fusion have increased 30-day complication rates compared to younger patients. METHODS: The American College of Surgeons National Surgical Quality Improvement Program was used to identify all patients undergoing instrumented posterolateral lumbar fusion between 2005 and 2011. Patients were stratified by decade cohorts as follows: &lt;65, 65 to 75, 75 to 85, and ≥85 years old. All 30-day complications were grouped as overall composite morbidity and were compared using multivariate analysis. RESULTS: A total of 1395 patients were identified and the overall 30-day complication rate was 11.47%. The complication rates were 9.04% and 14.05% for patients younger than 65 and older than 65, respectively. When stratified by decade cohorts, the complication rates were 9.04% for the &lt;65 cohort, 13.46% for the 65 to 75 cohort, 16.17% for the &gt;75 to 85 cohort, and 4.00% for the ≥85 cohort. Multivariable regression analysis revealed no statistically significant difference between the &lt;65 and ≥65 age cohorts (odds ratio = 1.26; 95% confidence interval: 0.87-2.19). After stratifying into age cohorts, multivariable analyses revealed no difference in odds of postoperative complication occurrence for any age cohort when compared with the referent group (&lt;65 years of age). CONCLUSION: Patients older than 65 years of age have significantly higher rates of complications after lumbar fusion when compared to younger patients. However, multivariable analysis revealed that age was not an independent risk factor for complication occurrence after lumbar fusion.

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