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.

Clinical Application of Prothrombin Complex Concentrate in Blood Management in Patients

2017 ◽  
Vol 37 (2) ◽  
pp. 49-56
Author(s):  
Sherri Ozawa ◽  
Tiffany Nelson
Keyword(s):  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Drug Discontinuation ◽  
Clotting Factors ◽  
Urgent Surgery ◽  
Anticoagulant Reversal ◽  
Fresh Frozen ◽  
Frozen Plasma

Management of patients receiving anticoagulants is a major factor in achieving better outcomes. Anticoagulant therapy may need to be discontinued or rapidly reversed before urgent surgery or invasive procedures. In these situations, treatment with concentrated vitamin K, fresh frozen plasma, and/or clotting factors can achieve more rapid anticoagulant reversal than can drug discontinuation alone. Activated prothrombin complex concentrate is used to treat hemophiliac patients with acquired factor VIII inhibitors. Nonactivated prothrombin complex concentrates are used for anticoagulant reversal. The concentrates are effective within minutes of dosing, providing a nearly immediate decrease in the international normalized ratio. The concentrates are lyophilized powders that can be quickly reconstituted, do not require ABO blood typing before use, and contain 25 times the concentration of vitamin K–dependent clotting factors compared with fresh frozen plasma. Studies suggest that the concentrates are associated with better clinical end points than is fresh frozen plasma.

Feasibility of a Collaborative, Prospective Interdisciplinary Review and Pharmacy-Based Dispensing Process for Prothrombin Complex Concentrate

2018 ◽  
Vol 52 (5) ◽  
pp. 454-461 ◽  
Author(s):  
Maria Stratton ◽  
Philip Grgurich ◽  
Kurt Heim ◽  
Sandra Mackey ◽  
Joseph D. Burns
Keyword(s):  
Adverse Events ◽  
Prothrombin Complex Concentrate ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Reversal Agent ◽  
Before And After ◽  
Measured Time ◽  
Fresh Frozen ◽  
Warfarin Reversal ◽  
Practice Methods

Background: Therapeutic options for rapid reversal of vitamin K antagonist therapy include 4-factor prothrombin complex concentrate (PCC4) and fresh frozen plasma (FFP). These agents have unique requirements for preparation, potential adverse effects, and cost-effectiveness considerations. Objective: To retrospectively assess whether our process for collaborative prospective review and pharmacy preparation facilitates timely and safe warfarin reversal with PCC4 as compared with FFP and to compare effectiveness and safety of the agents in practice. Methods: We performed a retrospective, single-center, before and after cohort study of patients requiring warfarin reversal for life-threatening bleeding or urgent invasive procedures over an 18-month period. The primary end point was time from ordering of reversal agent to administration. Secondary end points measured time to therapeutic effect and rates of adverse events. Results: Of 98 patients studied, 72 received FFP, and 26 received PCC4. The median times from ordering to administration of FFP and PCC4 were 69 and 44 minutes, respectively ( P = 0.015). Median time from ordering to end of infusion was significantly shorter for PCC4 compared with FFP (54 vs 151 minutes, respectively; P < 0.0001). In all, 72% of PCC4 patients and 28% of FFP patients achieved the goal international normalized ratio (INR) of ≤1.4 at the first INR check ( P < 0.0001). Adverse reactions occurred in 4% of patients in each group. Conclusion: In routine clinical practice incorporating collaborative prospective review and dispensing from the institution’s pharmacy, PCC4 was associated with faster administration, a higher rate of INR correction, and similar rates of adverse events compared with FFP.

Predisposing factors for enlargement of intracerebral hemorrhage in patients treated with warfarin

2003 ◽  
Vol 89 (02) ◽  
pp. 278-283 ◽  
Author(s):  
Kazuo Minematsu ◽  
Hiroaki Naritomi ◽  
Toshiyuki Sakata ◽  
Takenori Yamaguchi ◽  
Masahiro Yasaka
Keyword(s):  
Logistic Regression Model ◽  
Prothrombin Complex Concentrate ◽  
Warfarin Therapy ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Predisposing Factors ◽  
Predisposing Factor ◽  
Fresh Frozen ◽  
Cerebral Hematoma ◽  
Frozen Plasma

SummaryTo elucidate predisposing factors for enlargement of intra-cerebral hematoma (ICH) during warfarin therapy, we reviewed 47 patients on warfarin who developed acute ICH and determined relationships among ICH enlargement, INR reversal and clinical data. Among 36 patients treated to counteract the effects of warfarin within 24 h of onset, ICH increased in 10 patients (enlarged group), but remained unchanged in the remaining 26 (unchanged group), while ICH remained unchanged in another 11 patients in whom the effect of warfarin was reversed after 24 h. The international normalized ratio (INR) was counteracted immediately in 11 patients treated with prothrombin complex concentrate (PCC) but gradually in the other 36 treated by reducing the dose of warfarin, or by administering vitamin K or fresh frozen plasma. Multivariate analysis with a logistic regression model showed an INR value <2.0 at admission or for 24 h after immediate INR correction with PCC prevented ICH enlargement (OR 0.069, 95%CI 0.006-0.789, p = 0.031). An INR value of >2.0 within 24 h of ICH seems an important predisposing factor for ICH enlargement.

A Protocol for the Rapid Normalization of INR in Trauma Patients with Intracranial Hemorrhage on Prescribed Warfarin Therapy

2008 ◽  
Vol 74 (9) ◽  
pp. 858-861 ◽  
Author(s):  
Michael Kalina ◽  
Glen Tinkoff ◽  
Adebayo Gbadebo ◽  
Paula Veneri ◽  
Gerard Fulda
Keyword(s):  
Intracranial Hemorrhage ◽  
Prothrombin Complex Concentrate ◽  
Warfarin Therapy ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Operative Intervention ◽  
Trauma Patients ◽  
Number Of Patients ◽  
Fresh Frozen ◽  
Factor Concentrate

Trauma patients on prescribed warfarin therapy sustaining intracranial hemorrhage can be difficult to manage. Rapid normalization of coagulopathy is imperative to operative intervention and may affect outcomes. To identify and expedite warfarin reversal, we designed a protocol to administer a prothrombin complex concentrate. A Proplex T protocol was instituted in May 2004. It dictated that trauma patients with an International Normalized Ratio (INR) greater than 1.5, history of prescribed warfarin therapy, and intracranial hemorrhage on CT scan receive a prothrombin complex concentrate for reversal of their coagulopathy. Neither the protocol nor the factor concentrate was validated for use in this subset of trauma patients; therefore, adherence to the protocol and use of the factor concentrate was not mandatory. Patients not administered the prothrombin complex concentrate received vitamin K and fresh-frozen plasma. The protocol resulted in an increased number of patients receiving Proplex T (54.3% vs 35.4%, P = 0.047). Protocol patients had improved times to normalization of INR (331.3 vs 737.8 minutes, P = 0.048), number of patients with reversal of coagulopathy (73.2% vs 50.9%, P = 0.026), and time to operative intervention (222.6 vs 351.3 minutes, P = 0.045) compared with control subjects. There were no differences in intensive care unit (ICU) days, hospital days, or mortality. The Proplex T protocol increased the number of patients who received prothrombin complex concentrate, provided rapid normalization of INR, and improved time to operative intervention.

Preprocedural Coagulation Studies in Pediatric Patients Undergoing Percutaneous Intervention for Appendiceal Abscesses

2015 ◽  
Vol 81 (9) ◽  
pp. 859-864 ◽  
Author(s):  
Sandra M. Farach ◽  
Paul D. Danielson ◽  
Nicole M. Chandler
Keyword(s):  
Bleeding Risk ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Percutaneous Intervention ◽  
Bleeding Complications ◽  
Poor Correlation ◽  
Appendiceal Abscess ◽  
Significant Difference ◽  
Fresh Frozen ◽  
Frozen Plasma

The literature reports poor correlation between coagulation screening and prediction of bleeding risk in children. Our aim is to determine whether there is a role for coagulation studies in children undergoing percutaneous intervention for appendiceal abscesses. A retrospective review of 1805 patients presenting with a diagnosis of appendicitis from September 2008 to September 2013 was performed. Patients presenting with appendiceal abscess who underwent percutaneous intervention were selected for further review (n = 131). A total of 76 patients (58%) had normal coagulation studies, whereas 55 (42%) had elevated values. An international normalized ratio ≥ 1.3 was found in 26 patients. Patients with normal coagulation values had an incidence of bleeding of 1.3 per cent. In the abnormal coagulation group, 8 patients received fresh frozen plasma before intervention, whereas 47 did not. There was one hematoma noted in each group with an incidence of bleeding of 3.6 per cent. The overall incidence of hematoma was 2.3 per cent with no significant difference in bleeding risk between the normal and abnormal coagulation groups. In conclusion, although many patients are found to have elevated coagulation studies, most do not have bleeding complications after intervention. There is poor correlation between coagulation screening and postprocedural outcomes evidenced by the low risk of bleeding.

scholarly journals Practical management for urgent reversal of oral anticoagulation in patients with acute intracerebral haemorrhage

2011 ◽  
Vol 2 (1S) ◽  
pp. 93
Author(s):  
Davide Imberti
Keyword(s):  
Vitamin K ◽  
Intracerebral Haemorrhage ◽  
Gold Standard ◽  
Prothrombin Complex Concentrate ◽  
Standard Treatment ◽  
Oral Anticoagulant Therapy ◽  
Fresh Frozen Plasma ◽  
Emergency Intervention ◽  
Fresh Frozen ◽  
Frozen Plasma

In case of intracerebral haemorrhage (ICH) during oral anticoagulant therapy (OAT) it is mandatory to obtain the fast and complete normalisation of haemostasis, in order to minimise the risk of haematoma enlargement. Furthermore, if neurosurgery is requested, the immediate correction of haemostatic balance allows the execution of emergency intervention, thus reducing the risk of intra- and post-surgical haemorrhagic complications. Currently prothrombin complex concentrate (PCC) in combination with vitamin K represents the gold standard treatment for patients with ICH during OAT. This treatment should be preferred to the administration of fresh frozen plasma (FFP) in order to guarantee a fast and almost immediate normalisation of blood coagulation.

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.

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