Prothrombin Complex Concentrate for Warfarin-Associated Intracranial Bleeding in Neurosurgical Patients: A Single-Center Experience

Objective: The number of patients presenting with warfarin-associated intracranial bleeding and needing neurosurgical intervention is growing. Prothrombin complex concentrate (PCC) is commonly used for anti-coagulation reversal before emergent surgery. We present our experience with PCC use in patients presenting with coagulopathy and needing urgent craniotomy. Methods: We retrospectively identified all patients presenting with intracranial bleeding and coagulopathy due to warfarin use, requiring urgent neurosurgical procedures, from January, 2014 (implementation of 4-PCC therapy) until December, 2016. For coagulation reversal, all patients received 4-PCC (Octaplex) and vitamin K. Results: Thirty-five consecutive patients (17 men; median age 72 years) were administered 4-PCC before emergent neurosurgical procedures. The majority of patients presented with traumatic subdural hematoma (62%) and spontaneous intracerebral hemorrhage (32%). All patients were taking warfarin. Median international normalized ratio (INR) on admission was 2.94 (range: 1.20 to 8.60). Median 4-PCC dose was 2000 I.U. (range: 500 I.U. to 3000 I.U.). There was a statically significant decrease in INR (p < 0.01), PT (p < 0.01), and PTT (p = 0.02) after 4-PCC administration. Postoperative INR values were ≤3.00 in all patients, and seven (20%) patients had normal INR values. There were no 4-PCC related complications. Four (11%) patients developed subdural/epidural hematoma and 20 (57%) patients died. Mortality was associated with lower Glasgow coma scale (GCS) score. Conclusions: The 4-PCC facilitates INR reversal and surgery in patients presenting with warfarin-associated coagulopathy and intracranial bleeding requiring urgent neurosurgical intervention.

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Deterioration After Mild Traumatic Brain Injury: A Single-Center Experience With Cost Analysis

Frontiers in Neurology ◽

10.3389/fneur.2021.588429 ◽

2021 ◽

Vol 12 ◽

Author(s):

Rafał Chojak ◽

Marta Koźba-Gosztyła ◽

Mateusz Pawłowski ◽

Bogdan Czapiga

Keyword(s):

Prognostic Model ◽

Brain Injuries ◽

Hospital Admissions ◽

Good Condition ◽

Neurosurgical Department ◽

Total Cost ◽

Single Center Experience ◽

Number Of Patients ◽

Gcs Score ◽

Neurosurgical Intervention

Background: Most traumatic brain injuries (TBIs) are mild (GCS score of 13–15). Patients with mild TBI (mTBI) are generally in good condition. In some cases, a neurological deterioration (manifested by a drop of ≥1 point in GCS score) can occur and neurosurgical intervention (NI) may be needed. Because of that, these patients are frequently admitted to a hospital for observation. The aim of our study was to determine the number of patients with mTBI that deteriorate or need NI. We also considered an economic aspect of hospital admissions of these patients.Methods: The study group consisted of 186 adult patients admitted to the neurosurgical department due to mTBI. Patients were divided into three groups according to an initial GCS score. The occurrence of deterioration, need for NI, length of stay (LOS), cost of stay and occurrence of death were analyzed.Results: The deterioration was observed in 7 (3.76%) out of all cases. In 3 (1.61%) of them, the NI was needed. The average LOS was 7.96 days and it was closely linked with an initial GCS score (p < 0.001). The total cost of stay of all patients included in this study was about 1,188,668 PLN (306,357 USD).Conclusion: The deterioration occurred in a small number of patients with mTBI, the need for NI was even less common. Hospitalization of these patients is expensive. Further studies with prognostic model helping decide on admission/discharge are necessary.

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

The American Surgeon ◽

10.1177/000313480807400919 ◽

2008 ◽

Vol 74 (9) ◽

pp. 858-861 ◽

Cited By ~ 20

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.

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Point-of-Care Testing in Neurosurgery

Seminars in Thrombosis and Hemostasis ◽

10.1055/s-0037-1599159 ◽

2017 ◽

Vol 43 (04) ◽

pp. 416-422 ◽

Cited By ~ 4

Author(s):

Lars Wessels ◽

Andreas Unterberg ◽

Christopher Beynon

Keyword(s):

Brain Injury ◽

Intracranial Hemorrhage ◽

Point Of Care ◽

Acute Brain Injury ◽

Neurosurgical Procedures ◽

Full Potential ◽

Neurosurgical Patients ◽

Life Threatening ◽

The Central Nervous System ◽

Neurosurgical Intervention

AbstractCoagulation disorders can have a major impact on the outcome of neurosurgical patients. The central nervous system is located within the closed space of the skull, and therefore, intracranial hemorrhage can lead to intracranial hypertension. Acute brain injury has been associated with alterations of various hemostatic parameters. Point-of-care (POC) techniques such as rotational thromboelastometry are able to identify markers of coagulopathy which are not reflected by standard assessment of hemostasis (e.g., hyperfibrinolysis). In patients with acute brain injury, POC test results have been associated with important outcome parameters such as mortality and need for neurosurgical intervention. POC devices have also been used to rapidly identify and quantify the effects of antithrombotic medication. In cases of life-threatening intracranial hemorrhage, this information can be valuable when deciding over administration of prohemostatic substances or immediate neurosurgical intervention. In elective neurosurgical procedures, POC devices can provide important information when unexpected bleeding occurs or in cases of prolonged operative time with subsequent blood loss. Initial experiences with POC devices in neurosurgical care have shown promising results but further studies are needed to characterize their full potential and limitations.

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COVID-19: changing patterns among neurosurgical patients from North India, efficacy of repeat testing, and inpatient prevalence

Neurosurgical FOCUS ◽

10.3171/2020.9.focus20705 ◽

2020 ◽

Vol 49 (6) ◽

pp. E7 ◽

Cited By ~ 1

Author(s):

Sushanta K. Sahoo ◽

Sivashanmugam Dhandapani ◽

Apinderpreet Singh ◽

Chandrashekhar Gendle ◽

Madhivanan Karthigeyan ◽

...

Keyword(s):

Local Community ◽

North India ◽

Polymerase Chain Reaction Test ◽

Neurosurgical Procedures ◽

Repeated Testing ◽

Probable Number ◽

Period Prevalence ◽

Number Of Patients ◽

Neurosurgical Patients ◽

Changing Patterns

OBJECTIVECOVID-19 has affected surgical practice globally. Treating neurosurgical patients with the restrictions imposed by the pandemic is challenging in institutions with shared patient areas. The present study was performed to assess the changing patterns of neurosurgical cases, the efficacy of repeated testing before surgery, and the prevalence of COVID-19 in asymptomatic neurosurgical inpatients.METHODSCases of non–trauma-related neurosurgical patients treated at the Postgraduate Institute of Medical Education and Research (PGIMER) before and during the COVID-19 pandemic were reviewed. During the pandemic, all patients underwent a nasopharyngeal swab reverse transcription–polymerase chain reaction test to detect COVID-19 at admission. Patients who needed immediate intervention were surgically treated following a single COVID-19 test, while stable patients who initially tested negative for COVID-19 were subjected to repeated testing at least 5 days after the first test and within 48 hours prior to the planned surgery. The COVID-19 positivity rate was compared with the local period prevalence. The number of patients who tested positive at the second test, following a negative first test, was used to determine the probable number of people who could have become infected during the surgical procedure without second testing.RESULTSOf the total 1769 non–trauma-related neurosurgical patients included in this study, a mean of 337.2 patients underwent surgery per month before COVID-19, while a mean of 184.2 patients (54.6% of pre–COVID-19 capacity) underwent surgery per month during the pandemic period, when COVID-19 cases were on the rise in India. There was a significant increase in the proportion of patients undergoing surgery for a ruptured aneurysm, stroke, hydrocephalus, and cerebellar tumors, while the number of patients seeking surgery for chronic benign diseases declined. At the first COVID-19 test, 4 patients (0.48%) tested were found to have the disease, a proportion 3.7 times greater than that found in the local community. An additional 5 patients tested positive at the time of the second COVID-19 test, resulting in an overall inpatient period prevalence of 1%, in contrast to a 0.2% national cumulative caseload. It is possible that COVID-19 was prevented in approximately 67.4 people every month by using double testing.CONCLUSIONSCOVID-19 has changed the pattern of neurosurgical procedures, with acute cases dominating the practice. Despite the fact that the pandemic has not yet reached its peak in India, COVID-19 has been detected 3.7 times more often in asymptomatic neurosurgical inpatients than in the local community, even with single testing. Double testing displays an incremental value by disclosing COVID-19 overall in 1 in 100 inpatients and thus averting its spread through neurosurgical services.

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Comparison of Fibrinolytic versus Surgical Therapy in the Treatment of Obstructive Prosthetic Valve Thrombosis: A Single-Center Experience

The Heart Surgery Forum ◽

10.1532/hsf98.20101062 ◽

2011 ◽

Vol 14 (2) ◽

pp. 87 ◽

Cited By ~ 6

Author(s):

Necip Ermis ◽

Hakan Atalay ◽

Hakan Altay ◽

Muhammet Bilgi ◽

Suleyman Binici ◽

...

Keyword(s):

New York ◽

Prosthetic Heart Valve ◽

Heart Association ◽

International Normalized Ratio ◽

Fibrinolytic Therapy ◽

Surgical Approaches ◽

Specific Patient ◽

Single Center Experience ◽

Surgery Group ◽

Valve Thrombosis

Objective: Prosthetic heart valve thrombosis (PVT) is a rare but severe cardiac condition. There are only a few data regarding comparison of the fibrinolytic and surgical approaches for the treatment of PVT. In this study, we compared the results of fibrinolytic therapy versus surgery in patients who presented to our institution with a diagnosis of obstructive-type PVT.Methods: From January 2001 to August 2008 in our institution, 33 patients who met clinical and echocardiographic criteria for obstructive-type PVT were included in the study. Fifteen of these patients underwent fibrinolytic treatment with streptokinase, which consisted of an initial bolus of 250,000 U followed by 100,000 U/h. Eighteen patients were treated with surgery.Results: The 2 groups had similar baseline characteristics, including New York Heart Association functional status, types and positions of prosthetic valves, international normalized ratio values, and presentation symptoms. Full hemodynamic success was achieved in 12 patients who underwent fibrinolytic therapy and in 15 patients in the surgery group. The mean (SD) streptokinase infusion time was 17.8 11.1 hours. Two major hemorrhages and 2 cases of systemic embolism were observed in the fibrinolytic group. The 2 groups did not differ with respect to mortality rate (P = .79). The duration of hospitalization was longer in the fibrinolytic group than in the surgery group (10.7 6.6 days versus 6.9 6.7 days, P = .045).Conclusions: Although fibrinolytic therapy is generally recommended for the treatment of PVT for specific patient groups, our results suggest that it may be as efficacious and safe as surgery, depending on patient selection.

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Neuroblastoma with intracerebral metastases and the need for neurosurgery: a single-center experience

Journal of Neurosurgery Pediatrics ◽

10.3171/2019.7.peds19143 ◽

2020 ◽

Vol 25 (1) ◽

pp. 51-56

Author(s):

Steffen Fleck ◽

Sascha Marx ◽

Clara Bobak ◽

Victoria Richter ◽

Stephan Nowak ◽

...

Keyword(s):

Pediatric Patients ◽

Neurosurgical Procedures ◽

Normal Brain ◽

Indications For Surgery ◽

Single Center ◽

Neurosurgical Procedure ◽

Oncological Treatment ◽

Single Center Experience ◽

Stage 4 ◽

Neurosurgical Treatment

OBJECTIVEIntracerebral metastases in neuroblastoma patients are rare, and information about the indication for and the outcome of neurosurgical procedures in this setting is scarce in the literature. The authors’ aim in the present study was to report a single-center experience with the neurosurgical treatment of intracerebral metastases in neuroblastoma.METHODSThis study is a retrospective single-center analysis of all neurosurgical strategies used in the treatment of intracerebral metastases in neuroblastoma patients.RESULTSBetween 2009 and 2017, 237 pediatric patients (94 girls, 143 boys) with a mean age of 39 months at diagnosis were treated for neuroblastoma. Five (2.1%) of the 237 patients had a neurosurgical procedure for intracerebral metastases. The metastases occurred a mean of 46 months after initial diagnosis. All of these patients had neuroblastoma stage 4. Indications for surgery were recurrent metastases after initial successful oncological treatment or progression of the metastasis under oncological treatment as well as deterioration of neurological function. Intraoperatively, the tumor usually had a distinguishable dissection plane but was infiltrative to adjacent nerves in some spots. Mean overall survival after the neurosurgical procedure was 22 months. Furthermore, in another 3 patients, a neurosurgical procedure was done for an intracranial but extracerebral metastasis.CONCLUSIONSNeurosurgical procedures for intracerebral metastases in neuroblastoma patients are rare and were performed in 2.1% of patients in the present study. Intracerebral metastases occurred during disease progression, and the prognosis after surgery was very limited. The main indications for surgery were rapid neurological deterioration or recurrence of the metastasis after initial successful oncological treatment. Intraoperatively, the metastases usually had a distinguishable dissection plane from the normal brain tissue.

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Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial

BMC Anesthesiology ◽

10.1186/s12871-021-01404-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Federico Longhini ◽

Laura Pasin ◽

Claudia Montagnini ◽

Petra Konrad ◽

Andrea Bruni ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Outcome ◽

Adverse Events ◽

Respiratory Rate ◽

Randomized Clinical Trial ◽

Protective Ventilation ◽

Adult Patients ◽

Control Group ◽

Neurosurgical Procedures ◽

Neurosurgical Patients

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.

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Evaluation of a Fixed-Dose Regimen of 4-Factor Prothrombin Complex Concentrate for Warfarin Reversal

Annals of Pharmacotherapy ◽

10.1177/1060028021992142 ◽

2021 ◽

pp. 106002802199214

Author(s):

Clare McMahon ◽

Joe Halfpap ◽

Qianqian Zhao ◽

Ana Bienvenida ◽

Anne E. Rose

Keyword(s):

Central Nervous System ◽

Nervous System ◽

Dose Regimen ◽

Prothrombin Complex Concentrate ◽

Primary Outcome ◽

International Normalized Ratio ◽

Fixed Dose ◽

Optimal Dosing ◽

Warfarin Reversal ◽

Higher Doses

Background: Fixed-dose (FD) regimens of 4-factor prothrombin complex concentrate (4F-PCC) may be effective for the emergent reversal of warfarin; however, the optimal dosing is unknown. Our institution transitioned to a FD regimen of 1000 or 2000 units of 4F-PCC based on indication. Objective: The purpose of this study is to report our experience with FD 4F-PCC compared with a historical weight-based dosing cohort for warfarin reversal. Methods: A retrospective analysis was conducted for 3 groups: central nervous system (CNS) bleeds regardless of international normalized ratio (INR), non-CNS bleeds with an initial INR ≤6, and non-CNS bleeds with an initial INR ≥6.1. The primary outcome of the study was achievement of the target INR. Results: There were 54 patients with a CNS bleed, 153 with a non-CNS bleed and INR ≤6, and 19 with a non-CNS bleed and INR ≥6.1. In the CNS bleeding group, weight-based and FD achieved target INR 79.4% and 70% ( P = 0.52). In the INR ≥6.1 non-CNS bleeding group, weight-based and FD achieved target INR 100% and 70% ( P = 0.21). In the INR ≤6 non-CNS bleeding group, weight-based and FD achieved target INR 86.4% and 57.5% ( P = 0.0002). Conclusion and Relevance: An FD strategy of 2000 units for warfarin reversal for CNS bleeds or INR ≥6.1 was comparable to weight-based dosing. The FD strategy of 1000 units for INR ≤6 achieved target INR less often than weight-based dosing. Application of findings suggest that higher doses may be needed to achieve target INR.

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A 7-Year Single-Center Experience of Transfemoral TAVI: Evolution of Surgical Activity and Impact on Vascular Outcome

Angiology ◽

10.1177/0003319717737665 ◽

2017 ◽

Vol 69 (6) ◽

pp. 532-539 ◽

Cited By ~ 3

Author(s):

Fabien Lareyre ◽

Juliette Raffort ◽

Carine Dommerc ◽

Yacoub Habib ◽

François Bourlon ◽

...

Keyword(s):

Academic Research ◽

Postoperative Mortality ◽

Single Center Experience ◽

Transcatheter Aortic Valve ◽

Number Of Patients ◽

Vascular Outcome ◽

Identity Changes ◽

Research Consortium ◽

Valve Implantation ◽

Transfemoral Tavi

Transcatheter aortic valve implantation (TAVI) has become a well-established alternative to open surgery to treat aortic stenosis. We describe our 7-year TAVI experience using transfemoral access and identity changes in surgical activity and evaluate its impact on postoperative vascular outcomes. Consecutive patients (N = 340) who underwent TAVI with percutaneous transfemoral access were retrospectively included and divided into 4 quartiles according to the date of intervention. Vascular outcomes were classified according to the Valve Academic Research Consortium 2 classification. The number of patients who underwent transfemoral TAVI increased over time and their clinical characteristics evolved, with a lower Society of Thoracic Surgeons score and less comorbidities. The material used evolved and TAVI could be performed despite higher iliac calcification and tortuosity scores. With experience, the procedural time, the postoperative length of stay at hospital, and the 30-day postoperative mortality significantly decreased. No significant change was observed for vascular outcome, except for minor hematoma. We witnessed an increase in transfemoral TAVI procedure, with changes in clinical and procedural characteristics associated with an improvement in postoperative outcomes.

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Effects of implementing rotational thromboelastometry in cardiac surgery: A retrospective cohort study

Journal of Perioperative Practice ◽

10.1177/1750458920950662 ◽

2021 ◽

pp. 175045892095066

Author(s):

Minna Kallioinen ◽

Mika Valtonen ◽

Marko Peltoniemi ◽

Ville-Veikko Hynninen ◽

Tuukka Saarikoski ◽

...

Keyword(s):

Cardiac Surgery ◽

Prothrombin Complex Concentrate ◽

Fresh Frozen Plasma ◽

Blood Products ◽

Rotational Thromboelastometry ◽

Number Of Patients ◽

Fresh Frozen ◽

The Mean ◽

To Receive ◽

Frozen Plasma

Since 2013, rotational thromboelastometry has been available in our hospital to assess coagulopathy. The aim of the study was to retrospectively evaluate the effect of thromboelastometry testing in cardiac surgery patients. Altogether 177 patients from 2012 and 177 patients from 2014 were included. In 2014, the thromboelastometry testing was performed on 56 patients. The mean blood drainage volume decreased and the number of patients receiving platelets decreased between 2012 and 2014. In addition, the use of fresh frozen plasma units decreased, and the use of prothrombin complex concentrate increased in 2014. When studied separately, the patients with a thromboelastometry testing received platelets, fresh frozen plasma, fibrinogen and prothrombin complex concentrate more often, but smaller amounts of red blood cells. In conclusion, after implementing the thromboelastometry testing to the practice, the blood products were given more cautiously overall. The use of thromboelastometry testing was associated with increased possibility to receive coagulation product transfusions. However, it appears that thromboelastometry testing was mostly used to assist in management of major bleeding.

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