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.

Emergency Oral Anticoagulant Reversal: The Relative Efficacy of Infusions of Fresh Frozen Plasma and Clotting Factor Concentrate on Correction of the Coagulopathy

1997 ◽  
Vol 77 (03) ◽  
pp. 477-480 ◽  
Author(s):  
Mike Makris ◽  
Mike Greaves ◽  
Wendy S Phillips ◽  
Steve Kitchen ◽  
Frits R Rosendaal ◽  
...  
Keyword(s):  
Vitamin K ◽  
Fresh Frozen Plasma ◽  
Factor Ix ◽  
Clotting Factor ◽  
Clotting Factors ◽  
Anticoagulant Reversal ◽  
Fresh Frozen ◽  
Pre Treatment ◽  
Clotting Factor Concentrates ◽  
Frozen Plasma

SummaryHaemorrhage, including intracranial bleeding, is a common, potentially lethal complication of warfarin therapy and rapid and complete reversal of anticoagulation may be life-saving. Fresh frozen plasma (FFP) and vitamin K are most frequently administered. Because of the variable content of vitamin K-dependent clotting factors in FFP, and the effects of dilution, the efficacy of this approach is open to doubt. We have therefore compared the effects of FFP and clotting factor concentrates on the INRs and clotting factor levels of orally anticoagulated subjects requiring rapid correction of their haemostatic defect. In many, the pre-treatment INR was considered to be dangerously above the target therapeutic range. In the 12 patients given FFP, the INR did not completely correct (range 1.6-3.8, mean 2.3) indicating an ongoing anticoagulated state in all. In contrast, the INR in 29 subjects given clotting factor concentrates was completely corrected in 28 (range 0.9-3.8, mean 1.3). Following treatment, marked differences were observed in clotting factor IX levels between the two groups. The median factor IX level was 19 u/dl (range 10-63) following FFP infusion and 68.5 u/dl (range 31-111) following concentrate. In FFP treated patients, poorer responses were also observed for each of the other vitamin K-depen- dent clotting factors but these were less marked than for factor IX, which was present in low concentrations in some batches of FFP. Thus, haemostatically effective levels of factor IX cannot be achieved, in most instances, by the conventional use of FFP in patients requiring reversal of their anticoagulant therapy. Clotting factor concentrates are the only effective option where complete and immediate correction of the coagulation defect is indicated in orally anticoagulated patients with life or limb-threatening haemorrhage.

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.

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.

Prophylactic correction of the international normalized ratio in neurosurgery: a brief review of a brief literature

2011 ◽  
Vol 114 (1) ◽  
pp. 9-18 ◽  
Author(s):  
Kelly L. West ◽  
Cory Adamson ◽  
Maureane Hoffman
Keyword(s):  
Bleeding Risk ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Coagulation Cascade ◽  
Bleeding Tendency ◽  
Invasive Procedures ◽  
Clinical Tool ◽  
Clotting Factors ◽  
Fresh Frozen ◽  
Frozen Plasma

Prophylactic fresh-frozen plasma (FFP) transfusion is often undertaken in hemodynamically stable patients with a minimally elevated international normalized ratio (INR) prior to invasive procedures, despite little evidence in support of this practice. The authors review the current literature in an attempt to clarify best clinical practice with regard to this issue. Although the activated partial thromboplastin time and prothrombin time–INR are useful laboratory tests to measure specific clotting factors in the coagulation cascade, in the absence of active bleeding or a preexisting coagulopathy, their utility as predictors of overall bleeding risk is limited. Several studies have shown an imperfect correlation between mild elevations in the INR and subsequent bleeding tendency. Furthermore, FFP transfusion is not always sufficient to achieve normal INR values in patients who have mild elevations (< 2) to begin with. Finally, there are risks associated with FFP transfusion, including potential transfusion-associated [disease] exposures as well as the time delay imposed by laboratory testing and transfusion administration prior to initiation of procedures. The authors propose that the current concept of a “normal” INR value warrants redefinition to make it a more meaningful clinical tool. Based on their review of the literature, the authors suggest that in a hemodynamically stable patient population there is a range of mildly prolonged INR values for which FFP transfusion is not beneficial, and is potentially harmful.

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.

Use of Prothrombin Complex Concentrate as an Adjunct to Fresh Frozen Plasma Shortens Time to Craniotomy in Traumatic Brain Injury Patients

Neurosurgery ◽  
2015 ◽  
Vol 76 (5) ◽  
pp. 601-607 ◽  
Author(s):  
Bellal Joseph ◽  
Viraj Pandit ◽  
Mazhar Khalil ◽  
Narong Kulvatunyou ◽  
Hassan Aziz ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Scale Score ◽  
Prothrombin Complex Concentrate ◽  
Warfarin Therapy ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Fresh Frozen ◽  
The Mean ◽  
Frozen Plasma

AbstractBACKGROUND:The use of prothrombin complex concentrate (PCC) to reverse acquired (coagulopathy of trauma) and induced coagulopathy (preinjury warfarin use) is well defined.OBJECTIVE:To compare outcomes in patients with traumatic brain injury without warfarin therapy receiving PCC as an adjunct to fresh frozen plasma (FFP) therapy compared with patients receiving FFP therapy alone.METHODS:All patients with traumatic brain injury coagulopathy without warfarin therapy who received PCC (25 IU/kg) in conjunction with FFP or FFP alone at our Level I trauma center were reviewed. Coagulopathy was defined as an international normalized ratio &gt;1.5. The groups (PCC + FFP vs FFP alone) were matched using propensity score matching on a 1:2 ratio for age, sex, Glasgow Coma Scale score, Injury Severity Score, head Abbreviated Injury Scale score, and international normalized ratio (INR) on presentation. The primary outcome measure was time to craniotomy. Secondary outcome measures were blood product requirements, cost of therapy, and mortality.RESULTS:A total of 1641 patients were reviewed, 222 of whom were included (PCC + FFP, 74; FFP, 148). The mean ± standard deviation age was 46.4 ± 21.7 years, the median (range) Glasgow Coma Scale score was 8 (3-12), and the mean ± standard deviation INR on presentation was 1.92 ± 0.6. PCC + FFP therapy was associated with an accelerated correction of INR (P = .001) and decrease in overall pack red blood cell (P = .035) and FFP (P = .041) administration requirement. Craniotomy was performed in 26.1% of patients (n = 58). Patients who received PCC + FFP therapy had faster time to craniotomy (P = .028) compared with patients who received FFP therapy alone.CONCLUSION:PCC as an adjunct to FFP decreases the time to craniotomy with faster correction of INR and concomitant decrease in the need for blood product requirement in patients with traumatic brain injury exclusive of prehospital warfarin therapy.

scholarly journals Perioperative Hemostatic Management of Patients Treated with Vitamin K Antagonists

2008 ◽  
Vol 109 (5) ◽  
pp. 918-926 ◽  
Author(s):  
Jerrold H. Levy ◽  
Kenichi A. Tanaka ◽  
Wulf Dietrich
Keyword(s):  
Vitamin K ◽  
Elective Surgery ◽  
Vitamin K Antagonists ◽  
Anticoagulation Therapy ◽  
International Normalized Ratio ◽  
Fresh Frozen Plasma ◽  
Factor Vii ◽  
Anticoagulation Reversal ◽  
Fresh Frozen ◽  
Frozen Plasma

Clinicians, including anesthesiologists, surgeons, and intensivists, are frequently called on to correct coagulopathy in patients receiving oral anticoagulation therapy. Before elective surgery, anticoagulation reversal may be undertaken over several days by discontinuing warfarin or vitamin K treatment, but rapid correction is required in an emergency. European and American guidelines recommend prothrombin complex concentrates (PCCs) for anticoagulation reversal in patients with life-threatening bleeding and an increased international normalized ratio. Compared with human fresh frozen plasma, PCCs provide quicker correction of the international normalized ratio and improved bleeding control. Although there are historic concerns regarding potential infectious and thrombotic risks with PCCs, current PCC formulations are much improved. Recombinant activated factor VII is a potential alternative to PCCs, but preclinical comparisons suggest that PCCs are more effective in correcting coagulopathy. Although many patients who require rapid reversal of warfarin are currently treated with fresh frozen plasma, PCCs should be considered as an alternative therapy.

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