scholarly journals Performance of Biopsy Needle With Therapeutic Injection System to Prevent Bleeding Complications

2013 ◽  
Vol 7 (1) ◽  
Author(s):  
Philip Wong ◽  
Kent J. Johnson ◽  
Roscoe L. Warner ◽  
Scott I. Merz ◽  
Grant H. Kruger ◽  
...  
Keyword(s):  
Blood Loss ◽  
Percutaneous Biopsy ◽  
Injection System ◽  
Bleeding Complications ◽  
Biopsy Needle ◽  
Therapeutic Injection ◽  
Third Stage ◽  
Renal Biopsies ◽  
Control Versus

Renal disease is epidemic in the United States with approximately 8 × 106 people having chronic kidney disease. Renal biopsies are widely used to provide essential diagnostic information to physicians. However, the risk of bleeding complications possibly leading to life-threatening situations results in the contra-indication of biopsy in certain patient populations. Safer renal biopsies will allow more accurate diagnosis and better management of this epidemic health problem. We report the preclinical testing of a novel biopsy device called the therapeutic injection system (TIS). The device introduces a third stage to the standard two-stage side-cut percutaneous biopsy process. The third stage is designed to reduce bleeding complications by injecting a hemostatic plug at the time of biopsy. Laboratory evaluation and preliminary in vivo animal testing using an anticoagulated porcine model of the TIS and Bard Monopty® (Bard Medical, Covington, GA) control device were performed. The hemostatic material Gelfoam® (Pfizer, Brussels, Belgium) was selected as the active material comprising the hemostatic plugs. The performance of two composite plugs, one composed of polyvinyl alcohol (PVA) combined in 2:1 and 12:1 ratios with the hemostatic material, and one plug composed of 100% hemostatic material were tested. Stroke sequence and hemostatic plug deployment were verified by sequential firing of the TIS biopsy needle into clear gelatin and ex vivo bovine kidney specimens. In vivo trials with porcine specimens revealed a significant reduction in blood loss (8.1 ± 3.9 ml, control versus 1.9 ± 1.6 ml, 12:1 PVA/hemostatic, TIS, α = 0.01, n = 6). The 100% hemostatic plug showed a substantial and immediate reduction in blood loss (9.2 ml, control versus 0.0 ml, TIS, n = 1). The prototype device was shown to work repeatedly and reliably in laboratory trials. Initial results show promise in this approach to control post biopsy bleeding. This solution maintains the simplicity and directness of the percutaneous approach, while not significantly changing the standard percutaneous biopsy procedure.

scholarly journals The efficacy of blind versus real-time ultrasound-guided percutaneous renal biopsy in developing country

2019 ◽  
Vol 7 ◽  
pp. 205031211984977 ◽  
Author(s):  
Wanjak Pongsittisak ◽  
Naphat Wutilertcharoenwong ◽  
Tanun Ngamvichchukorn ◽  
Sathit Kurathong ◽  
Chutima Chavanisakun ◽  
...  
Keyword(s):  
Renal Biopsy ◽  
Real Time ◽  
Resource Constraint ◽  
Bleeding Complications ◽  
Ultrasound Guided ◽  
Biopsy Needle ◽  
Percutaneous Renal Biopsy ◽  
Renal Biopsies ◽  
Lower Egfr ◽  
Adequate Tissue

Introduction: Renal biopsy is a useful diagnostic procedure. In developing countries, two techniques of renal biopsy, blind percutaneous renal biopsy and real-time ultrasound-guided percutaneous renal biopsy, have been performed. The majority of studies compared these using different types and sizes of biopsy needle. The aim of this study was to compare both techniques in resource constraint country. Method: We reviewed renal biopsy database, between 1 January 2014 to 30 June 2017. The primary outcome was the total number of glomeruli. The other outcomes were tissue adequacy and bleeding complications. We also analyzed multivariable logistic regression to find factors associated with tissue adequacy and bleeding complications. Result: Of the 204 renal biopsies, 100 were blind percutaneous renal biopsy and 104 real-time ultrasound-guided percutaneous renal biopsy. The number of native renal biopsies was 169 (82.8%). Baseline characteristics of two groups were comparable. The mean number of total glomeruli from real-time ultrasound-guided percutaneous renal biopsy was significantly more than blind percutaneous renal biopsy (20.8 ± 12.1 vs 16.0 ± 13.0, p = 0.001). The real-time ultrasound-guided percutaneous renal biopsy obtained more adequate tissues than blind percutaneous renal biopsy (45.2% vs 16%, p < 0.001) and was the only factor associated with adequate tissue. Moreover, 16 renal biopsies from blind percutaneous renal biopsy obtained inadequate tissue. The overall bleeding complications were not statistically different. We found being female, lower eGFR and lower hematocrit were associated with bleeding complications. Conclusion: In comparison with blind percutaneous renal biopsy, real-time ultrasound-guided percutaneous renal biopsy obtained more adequate tissue and number of glomeruli. While the complications of both were comparable. We encourage to practice and perform real-time ultrasound-guided percutaneous renal biopsy in resource constraint countries.

Determination and Treatment of Disorders of Primary Haemostasis

1999 ◽  
Vol 19 (04) ◽  
pp. 168-175 ◽  
Author(s):  
M. Weippert-Kretschmer ◽  
V. Kretschmer
Keyword(s):  
Platelet Function ◽  
Bleeding Risk ◽  
Bleeding Complications ◽  
Bleeding Tendency ◽  
Platelet Counts ◽  
Platelet Function Disorders ◽  
Perioperative Bleeding ◽  
Before And After ◽  
Low Sensitivity

SummaryPerioperative bleeding complications due to disorders of primary haemostasis are often underestimated. Routine determination of primary haemostasis is still problematic. The in vivo bleeding time (BT) shows low sensitivity and high variability. In this contribution the results and experiences with the IVBT having been obtained in various studies and during 10 years of routine use are reported. Patients and Methods: Blood donors before and after ASA ingestion, patients with thrombocytopenia as well as congenital and acquired platelet function disorders. Monitoring of desmopressin efficacy. IVBT with Thrombostat 4000 (tests with CaCl2 = TST-CaCl2 and ADP = TST-ADP) and PFA-100 (test cartridges with epinephrine = PFA-EPI and ADP = PFA-ADP). Results and Conclusions: IVBT becomes abnormal with platelet counts <100,000/μl. With platelet counts <50,000/μl the results are mostly outside the methodical range. IVBT proved clearly superior to BT in von Willebrand syndrome (vWS). All 16 patients with vWS were detected by PFA-EPI, whereas with BT 7 of 10 patients with moderate and 1 of 6 patients with mild forms of vWS were spotted. The majority of acquired and congenital platelet function disorders with relevant bleeding tendency were detectable by IVBT. Sometimes diagnostic problems arose in case of storage pool defect. Four to 12 h after ingestion of a single dose of 100 mg ASA the TST-CaCl2 became abnormal in all cases, the PFA-EPI only in 80%. However, the ASA sensitivity of TST-CaCl2 proved even too high when looking for perioperative bleeding complications in an urological study. Therefore, the lower ASS sensitivity of the PFA-100 seems to be rather advantageous for the estimation of a real bleeding risk. The good efficacy of desmopressin in the majority of cases with mild thrombocytopenia, congenital and acquired platelet function disorders and even ASS-induced platelet dysfunction could be proven by means of the IVBT. Thus IVBT may help to increase the reliability of the therapy. However, the IVBT with the PFA-100 is not yet fully developed. Nevertheless, routine use can be recommended when special methodical guidelines are followed.

Improved hemostasis with superactive analogs of factor VIIa in a mouse model of hemophilia A

Blood ◽  
2003 ◽  
Vol 102 (10) ◽  
pp. 3615-3620 ◽  
Author(s):  
Mikael Tranholm ◽  
Kim Kristensen ◽  
Annemarie T. Kristensen ◽  
Charles Pyke ◽  
Rasmus Røjkjær ◽  
...  
Keyword(s):  
Blood Loss ◽  
Bleeding Time ◽  
Hemophilia A ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Intrinsic Activity ◽  
Hemostatic Effect ◽  
Therapeutic Doses ◽  
Hemostatic Effects

AbstractIt is currently debated whether the mechanism of action of therapeutic doses of recombinant factor VIIa (rFVIIa, Novo-Seven) relies on the tissue factor (TF)-independent activity of the enzyme. The present study was conducted to investigate the in vivo hemostatic effects of rFVIIa and 3 analogs thereof with superior intrinsic activity (FVIIaIIa, K337A-FVIIaIia, and M298Q-FVIIa) in mice with antibody-induced hemophilia A. A highly significant dose response was observed for the bleeding time and blood loss for each of the rFVIIa variants. The bleeding time and blood loss were normalized after administration of 10 mg/kg rFVIIa, 3 mg/kg K337A-FVIIaIia, and 3 mg/kg M298Q-FVIIa, indicating a potency of these FVIIa analogs 3-4 times above that of rFVIIa in FVIII-depleted mice. The different in vivo potencies of the various forms of FVIIa could not be explained by the pharmacokinetics. Histopathological evaluation of kidneys revealed no signs of treatment-related pathological changes even after treatment with the superactive variants. The fact that FVIIa analogs with enhanced intrinsic activity are more efficacious in the murine hemophilia A model strongly suggests that the TF-independent procoagulant activity of FVIIa contributes to its clinical hemostatic effect. (Blood. 2003; 102:3615-3620)

Systemic hemostatic and hemostasiological effects of fibrin monomer in low dose under warfarin action in experiment

2019 ◽  
Author(s):  
В.М. Вдовин ◽  
А.П. Момот ◽  
Д.А. Орехов ◽  
И.Г. Толстокоров ◽  
В.О. Шевченко ◽  
...  
Keyword(s):  
Liver Injury ◽  
Blood Loss ◽  
Prothrombin Complex Concentrate ◽  
Coagulation Factors ◽  
International Normalized Ratio ◽  
Blood Coagulation Factors ◽  
Circulating Blood Volume ◽  
Hemostatic Effect ◽  
Blood Loss Volume

Введение. Ранее было показано, что фибринмономер (ФМ) в низких дозировках обладает системным гемостатическим действием в условиях дозированной травмы. Авторами выдвинута гипотеза, согласно которой ФМ способен оказывать регулирующее гемостатическое действие in vivo на фоне сниженного гемостатического потенциала. Цель исследования: изучение системных гемостатических и гемостазиологических эффектов ФМ на фоне дозированной травмы печени при гипокоагуляции, обусловленной приемом варфарина. Материалы и методы. В работе использовали 40 кроликов породы Шиншилла. Для индукции кумаринобусловленной гипокоагуляции животным per os вводили варфарин в дозе 0,4 0,5 мг/кг 14 дней до достижения международного нормализованного отношения (МНО) более 2,0. Далее животным в краевую вену уха вводили концентрат факторов протромбино вого комплекса (КФПК) в дозе 40 ЕД/кг, ФМ в дозе 0,25 мг/кг или плацебо. Через 1 ч после введения препаратов наносили травму печени и оценивали кровопотерю (в процентах от объема циркулирующей крови). Исследовали число тромбоцитов, активированное парциальное тромбопластиновое время, МНО, содержание фибриногена и Ддимера, оценивали результаты тромбоэластографии крови. Результаты. Объем кровопотери в группах животных после внутривенного введения ФМ и КФПК на фоне приема варфарина был в 9,1 раза и 6,7 раза меньше, соответственно, по сравнению с группой плацебо, получавшей тот же антикоагулянт. Вместе с тем ФМ не влиял на параметры коагулограммы (отсутствие видимого гемостазиологического эффекта) и тромбоэластограммы, тогда как применение КФПК в качестве антидота варфарина сопровождалось нормализацией параметров тромбоэластометрии и коррекцией гипокоагуляционного сдвига по МНО. Заключение. Установлено, что ФМ способен проявлять свое системное гемостатическое действие в условиях сниженного тромбинообразования, обусловленного нарушением синтеза витамин Кзависимых факторов свертывания крови. Данное действие реализуется без признаков восстановления гемостатического равновесия. Introduction. It was shown earlier that fibrinmonomer (FM) in low doses had a systemic hemostatic effect in a controlled injury condition. The authors suggest that FM is able to exert a regulating hemostatic effect in vivo under reduced hemostatic potential. Aim: to study the systemic hemostatic and hemostasiological effects of FM under controlled liver injury during hypocoagulation caused by warfarin administration. Materials and methods. In this study 40 Chinchilla rabbits were used. For the induction of coumarinmediated hypocoagulation, animals were administered per os warfarin at a dose of 0.4 0.5 mg/kg for 14 days, until an international normalized ratio (INR) was more than 2.0. Subsequently, a prothrombin complex concentrate (PCC) at a dose of 40 U/kg, FM at a dose of 0.25 mg/kg or placebo were administered into the marginal ear vein of the animals. An hour later, a liver injury was inflicted and blood loss was assessed (in percents of the circulating blood volume). The number of platelets, activated partial thromboplastin time, INR, levels of fibrinogen and Ddimer were studied and the results of blood thromboelastography were evaluated. Results. Blood loss volume in animals groups after intravenous administration of FM and PPC, under warfarin reception, was 9.1 times and 6.7 times less, respectively, compared to the placebo group receiving the same anticoagulant. However, FM did not affect on coagulogram parameters (no visible hemostasiological effect) and thromboelastogram, whereas the use of PPC as warfarin antidote was accompanied by the normalization of thromboelastometry parameters and hypocoagulation shift correction according to INR. Conclusion. It was found that FM able to manifest its systemic hemostatic effect in conditions of reduced thrombin formation caused by impaired synthesis of vitamin Kdependent blood coagulation factors. This effect is implemented without any signs of recovery of hemostatic balance.

scholarly journals Sulfated non-anticoagulant heparin derivative modifies intracellular hemoglobin, inhibits cell sickling in vitro, and prolongs survival of sickle cell mice under hypoxia

Haematologica ◽  
2021 ◽  
Author(s):  
Osheiza Abdulmalik ◽  
Noureldien H. E. Darwish ◽  
Vandhana Muralidharan-Chari ◽  
Maii Abu Taleb ◽  
Shaker A. Mousa
Keyword(s):  
Sickle Cell ◽  
Inflammatory Responses ◽  
Anticoagulant Activity ◽  
Single Point ◽  
Bleeding Complications ◽  
Single Point Mutation ◽  
Repeated Dosing ◽  
Heparin Derivative

Sickle cell disease (SCD) is an autosomal recessive genetic disease caused by a single point mutation, resulting in abnormal sickle hemoglobin (HbS). During hypoxia or dehydration, HbS polymerizes to form insoluble aggregates and induces sickling of red blood cells (RBCs). RBC sickling increases adhesiveness of RBCs to alter the rheological properties of the blood and triggers inflammatory responses, leading to hemolysis and vaso-occlusive crisis sequelae. Unfractionated heparin (UFH) and low-molecular weight heparins (LMWH) have been suggested as treatments to relieve coagulation complications in SCD. However, they are associated with bleeding complications after repeated dosing. An alternative sulfated nonanticoagulant heparin derivative (S-NACH) was previously reported to have none to low systemic anticoagulant activity and no bleeding side effects, and it interfered with P-selectindependent binding of sickle cells to endothelial cells, with concomitant decrease in the levels of adhesion biomarkers in SCD mice. S-NACH has been further engineered and structurally enhanced to bind with and modify HbS to directly inhibit sickling, thus employing a multimodal approach. Here, we show that S-NACH can (i) directly engage in Schiff-base reactions with HbS to decrease RBC sickling under both normoxia and hypoxia in vitro, ii) prolong the survival of SCD mice under hypoxia, and (iii) regulate the altered steady state levels of pro- and antiinflammatory cytokines. Thus, our proof of concept in vitro and in vivo preclinical studies demonstrate that the multimodal S-NACH is a highly promising candidate for development into an improved and optimized alternative to LMWHs for the treatment of patients with SCD.

Risk factors for bleeding in pediatric post-cardiotomy patients requiring ECLS

Perfusion ◽  
2009 ◽  
Vol 24 (3) ◽  
pp. 191-197 ◽  
Author(s):  
Kathryn Nardell ◽  
Gail M Annich ◽  
Jennifer C Hirsch ◽  
Cathe Fahrner ◽  
Pat Brownlee ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Loss ◽  
Blood Product ◽  
Life Support ◽  
Extracorporeal Life Support ◽  
Bleeding Complications ◽  
Excessive Bleeding ◽  
Surgical Exploration ◽  
Platelet Counts ◽  
Protamine Administration

Background/Objective: There is limited literature documenting bleeding patterns in pediatric post-cardiotomy patients on extracorporeal life support (ECLS). This retrospective review details bleeding complications and identifies risk factors for bleeding in these patients. Methods: Records from 145 patients were reviewed. Patients were divided into excessive (E) and non-excessive (NE) bleeding groups based on blood loss. Results: Excessive bleeding occurred predominantly from 0-6h. Longer CPB duration (NE=174±8min; E=212±16; p=0.02) and lower platelet counts (NE=104.8±50K; E=84.3±41K; p=0.01) were associated with excessive bleeding during the first 6h (p=0.005). Use of intraoperative protamine with normal platelets was associated with decreased bleeding from 7-12h post-ECLS (p=0.002). Most mediastinal exploration occurred >49h post-ECLS, with decreased bleeding post-exploration in E patients. Conclusions: The majority of pediatric post-cardiotomy ECLS bleeding occurs early after support initiation. Longer CPB time and thrombocytopenia increased bleeding 0-6h post-ECLS. Since early bleeding may be coagulopathic in origin, an approach to minimize bleeding includes protamine administration and aggressive blood product replacement with target platelet counts of 100-120K. Surgical exploration should follow if additional hemostasis is necessary.

Implementation of the Surgical Apgar Score in Laboratory Animal Science: A Showcase Pilot Study in a Porcine Model and a Review of the Literature

2021 ◽  
pp. 1-11
Author(s):  
Lisa Ernst ◽  
Anna Maria Kümmecke ◽  
Leonie Zieglowski ◽  
Wenjia Liu ◽  
Mareike Schulz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Literature Review ◽  
Blood Loss ◽  
Abdominal Surgery ◽  
Laboratory Animal ◽  
Large Animal ◽  
Animal Science ◽  
Surgical Apgar Score ◽  
Laboratory Animal Science

<b><i>Introduction:</i></b> In an attempt to further improve surgical outcomes, a variety of outcome prediction and risk-assessment tools have been developed for the clinical setting. Risk scores such as the surgical Apgar score (SAS) hold promise to facilitate the objective assessment of perioperative risk related to comorbidities of the patients or the individual characteristics of the surgical procedure itself. Despite the large number of scoring models in clinical surgery, only very few of these models have ever been utilized in the setting of laboratory animal science. The SAS has been validated in various clinical surgical procedures and shown to be strongly associated with postoperative morbidity. In the present study, we aimed to review the clinical evidence supporting the use of the SAS system and performed a showcase pilot trial in a large animal model as the first implementation of a porcine-adapted SAS (pSAS) in an in vivo laboratory animal science setting. <b><i>Methods:</i></b> A literature review was performed in the PubMed and Embase databases. Study characteristics and results using the SAS were reported. For the in vivo study, 21 female German landrace pigs have been used either to study bleeding analogy (<i>n</i> = 9) or to apply pSAS after abdominal surgery in a kidney transplant model (<i>n</i> = 12). The SAS was calculated using 3 criteria: (1) estimated blood loss during surgery; (2) lowest mean arterial blood pressure; and (3) lowest heart rate. <b><i>Results:</i></b> The SAS has been verified to be an effective tool in numerous clinical studies of abdominal surgery, regardless of specialization confirming independence on the type of surgical field or the choice of surgery. Thresholds for blood loss assessment were species specifically adjusted to &#x3e;700 mL = score 0; 700–400 mL = score 1; 400–55 mL score 2; and &#x3c;55 mL = score 3 resulting in a species-specific pSAS for a more precise classification. <b><i>Conclusion:</i></b> Our literature review demonstrates the feasibility and excellent performance of the SAS in various clinical settings. Within this pilot study, we could demonstrate the usefulness of the modified SAS (pSAS) in a porcine kidney transplantation model. The SAS has a potential to facilitate early veterinary intervention and drive the perioperative care in large animal models exemplified in a case study using pigs. Further larger studies are warranted to validate our findings.

scholarly journals B-lynch suture in the management of uterine atony during caesarean section section

2019 ◽  
Vol 8 (5) ◽  
pp. 1946
Author(s):  
Sudha H. C. ◽  
Jaganathan Pairu ◽  
Kamalakshi .
Keyword(s):  
Caesarean Section ◽  
Blood Transfusion ◽  
Blood Loss ◽  
Radical Surgery ◽  
Randomized Study ◽  
Uterine Atony ◽  
Study Group ◽  
High Risk Factors ◽  
Advanced Technologies ◽  
Third Stage

Background: Third stage of labour is still the “sword of Damocle’s” hanging above an obstetrician , inspite  of  today’s advanced technologies and personal care .The importance in the management of this deadly stage lies in the anticipation of complications and being quick enough to treat them timely.  Hence in such scenarios, B-lynch suture is most popular method in treatment of uterine atony during caesarean section. The objective is to study and evaluate the cases in which the B-Lynch suture was used to treat the uterine atony during caesarean section.Methods: A prospective randomized study consisting of 50 women with high risk factors for atonic pph during caesarean section were included as study group patients were subjected to B-Lynch suture application when conventional drugs failed to control PPH. Blood loss was measured using a measuring jar. The fall in Hb% and the need for blood transfusion, and the need for hysterectomy as a last resort to save the life was evaluated.Results: The average blood loss was 1490 ml and the majority of patients had reduction in Hb% from 1.1-1.5 gm% (52%), 36% of the patients did not receive any blood transfusion after B-Lynch suture, and in 80% of cases hysterectomy was avoided.Conclusions: Our study shows cases treated with B-Lynch procedure showed that it is an effective method of containing pph.  It has the advantage of being applied easily and safely. It should be attempted when conservative management fails and before any radical surgery is considered.

Targeting Nanotechnologies for the Treatment of Thrombosis and Cardiovascular Disease

2019 ◽  
Vol 46 (05) ◽  
pp. 606-621
Author(s):  
Jason Sam Palazzolo ◽  
Erik Westein ◽  
Christoph Eugen Hagemeyer ◽  
Ting-Yi Wang
Keyword(s):  
Drug Delivery Systems ◽  
Heart Diseases ◽  
Venous Blood ◽  
Standard Of Care ◽  
Therapeutic Interventions ◽  
Bleeding Complications ◽  
Preclinical Studies ◽  
Medical Issues ◽  
Blood Clots

AbstractThrombosis is characterized by the formation of in vivo blood clots that are localized within arterial or venous blood vessels. These thrombi form beyond the need for physiologically healthy hemostatic responses and can lead to significant medical issues for affected individuals. Unfortunately, the existing standard-of-care therapies for treating thrombosis are systemic in their therapeutic design; therefore, they interfere with the patient's physiological hemostasis. Examples of the severe clinical side effects commonly associated with currently available therapies include, but are not limited to, bleeding complications. Therefore, there is a profound demand for novel therapeutic interventions that can circumvent these debilitating complications, while offering improved therapeutic efficacy. Recent advancements in nanotechnology present an opportunity to develop novel and improved drug delivery systems to meet this clinical demand. Preclinical investigations have begun to uncover the potential of nanotechnology, particularly in the treatment of thrombosis and also in nonhemostatic cardiovascular diseases. This article reviews recent preclinical studies aimed at developing a diverse array of different nanotechnologies for treating thrombosis as well as heart diseases. This review will also outline the limitations with current nanotechnologies and what challenges need to be overcome to translate these novel therapies to the clinic.

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