scholarly journals Effectiveness and Safety of Nadroparin Therapy in Preterm and Term Neonates with Venous Thromboembolism

2021 ◽  
Vol 10 (7) ◽  
pp. 1483
Author(s):  
Jeanine Sol ◽  
Marit Boerma ◽  
Irene Klaassen ◽  
Sinno Simons ◽  
Bregje Witjes ◽  
...  

Introduction: Optimal neonatal nadroparin dosages to treat venous thromboembolism (VTE) are unknown. Objective: To evaluate therapeutic nadroparin dosages to reach therapeutic target ranges (TTR: 0.5–1.0 International Unit (IU)/mL) and the effectiveness and safety of nadroparin in neonatal VTE. Methods: Retrospective study including neonates with VTE on nadroparin in a tertiary center between 2007 and 2018. Two groups were distinguished: neonates before (group 1) and after (group 2) switch to higher starting dosages in 2014. Results: Sixty-one neonates (44 preterm, 17 term) with 64 VTEs were included. TTR was reached in 32/64 (50%) VTEs (group 1: 35.7%; group 2: 61.1%). Median nadroparin dosage to reach TTR was 197 (97.9–330.3) IU/kg/12 h. No therapy-related deaths occurred. Recurrent VTE developed in 6 (9.8%) neonates. Complete clot resolution was observed in 31/41 (75.6%) VTEs. TTR was reached in 58.1% VTEs with complete clot resolution. No major bleeding occurred. Non-major clinically relevant bleedings occurred in 3/64 (4.7%) VTEs, consisting of large hematomas due to the use of subcutaneous catheters. Conclusions: High nadroparin dosages are needed to reach TTR in neonates, which seem to be safe. Clot resolution may occur without reaching TTR. Subcutaneous catheters may cause important bleeding complications.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4369-4369
Author(s):  
Kyoung Ha Kim ◽  
Nam Seok Ham ◽  
Yang Ki Kim ◽  
Hyung Suk Choi ◽  
You Sung Suh ◽  
...  

Abstract Abstract 4369 BACKGROUND Since October 2010, rivaroxaban has been approved by Korean government to be covered by national health insurance reimbursement system as thromboprophylaxis after total hip arthroplasty and total knee arthroplasty. However, there is no available data on outcomes of rivaroxaban as thromboprophylaxis in Korea. We performed a retrospective study to compare the efficacy and safety of venous thromboembolism prophylaxis with enoxaparin or rivaroxaban in 195 consecutive patients undergoing major orthopaedic surgery at our center. METHODS This study retrospectively reviewed the medical records of the 195 patients who underwent a total hip replacement arthroplasty or total knee replacement arthroplasty and received thromboprophoylaxis with enoxaparin or rivaroxaban at Soonchunhyang University Hospital between March 2009 and May 2012. Each patient's medical records included information on age, sex, comorbidities (active malignant disease, renal insufficiency), treatment details (type of surgery, type of anesthesia, duration of surgery,), duration of prophylaxis, efficacy (death, pulmonary embolism, deep vein thrombosis), safety (major bleeding, cerebrovascular accident), cause of drug interruption. RESULTS Of 195 patients, 129 patients received thromboprophylaxis with enoxaparin (group 1; our hospital standard since March 2009), 66 received rivaroxaban (group 2; our hospital standard since February 2011). Symptomatic venous thromboembolism was found in 0.7 % of patients in the group 1 (1/129 patients) compared to 1.5 % of group 2 (1/66 patients; p=0.627). No significant differences in the rates of symptomatic VTE were found. However, patients with received rivaroxaban had significantly more rates of major bleeding (0 in group 1 vs 3% (2/66 patients) in group 2; p=0.047). Although group 1 patients were planed receiving thromboprophylaxis with rivaroxaban from day one post operatively, mean time from the end of surgery to first rivaroxaban intatake was 4.2 days. CONCLUSIONS Despite lower compliance in rivaroxaban group, venous thromboembolism prophylaxis with rivaroxaban is not inferior to prophylaxis with enoxaparin with regard to the prevention of symptomatic venous thromboembolisms. But, more bleeding complications and wound problems revealed in rivaroxaban group. Further studies and experiences are needed to assess the efficacy and safety of rivaroxaban in clinical practice. Disclosures: No relevant conflicts of interest to declare.


Author(s):  
Caroline S. B. Veen ◽  
Elise J. Huisman ◽  
Lorenzo G. R. Romano ◽  
Celesta W. A. Schipaanboord ◽  
Marjon H. Cnossen ◽  
...  

Abstract Background The most optimal management for patients with bleeding of unknown cause (BUC) is unknown, as limited data are available. Objective Evaluate management and outcome of surgical procedures and deliveries in patients with BUC. Materials and Methods All patients ≥12 years of age, referred to a tertiary center for a bleeding tendency, were included. Bleeding phenotype was assessed and hemostatic laboratory work-up was performed. Patients were diagnosed with BUC or an established bleeding disorder (BD). Data on bleeding and treatment during surgical procedures and delivery following diagnosis were collected. Results Of 380 included patients, 228 (60%) were diagnosed with BUC and 152 (40%) with an established BD. In 14/72 (19%) surgical procedures major bleeding occurred and 14/41 (34%) deliveries were complicated by major postpartum hemorrhage (PPH). More specifically, 29/53 (55%) of the BUC patients who underwent surgery received prophylactic treatment to support hemostasis. Despite these precautions, 4/29 (14%) experienced major bleeding. Of BUC patients not treated prophylactically, bleeding occurred in 6/24 (25%). Of pregnant women with BUC, 2/26 (8%) received prophylactic treatment during delivery, one women with and 11 (46%) women without treatment developed major PPH. Conclusion Bleeding complications are frequent in BUC patients, irrespective of pre- or perioperative hemostatic treatment. We recommend a low-threshold approach toward administration of hemostatic treatment in BUC patients, especially during delivery.


2008 ◽  
Vol 100 (09) ◽  
pp. 435-439 ◽  
Author(s):  
Javier Trujillo-Santos ◽  
José Nieto ◽  
Gregorio Tiberio ◽  
Andrea Piccioli ◽  
Pierpaolo Micco ◽  
...  

SummaryCancer patients with acute venous thromboembolism (VTE) have an increased incidence of recurrences and bleeding complications while on anticoagulant therapy. Methods RIETE is an ongoing registry of consecutive patients with acute VTE. We tried to identify which cancer patients are at a higher risk for recurrent pulmonary embolism (PE), deep vein thrombosis (DVT) or major bleeding. Up to May 2007, 3, 805 cancer patients had been enrolled in RIETE. During the first three months of follow-up after the acute, index VTE event, 90 (2.4%) patients developed recurrent PE, 100 (2.6%) recurrent DVT, 156 (4.1%) had major bleeding. Forty patients (44%) died of the recurrent PE,46 (29%) of bleeding. On multivariate analysis, patients aged <65 years (odds ratio [OR]: 3.0; 95% confidence interval [CI]: 1.9–4.9), with PE at entry (OR: 1.9; 95% CI: 1.2–3.1), or with <3 months from cancer diagnosis to VTE (OR: 2.0; 95% CI: 1.2–3.2) had an increased incidence of recurrent PE. Those aged <65 years (OR: 1.6; 95% CI: 1.0–2.4) or with <3 months from cancer diagnosis (OR: 2.4; 95% CI: 1.5–3.6) had an increased incidence of recurrent DVT. Finally, patients with immobility (OR: 1.8; 95% CI: 1.2–2.7), metastases (OR: 1.6; 95% CI: 1.1–2.3), recent bleeding (OR: 2.4; 95% CI: 1.1–5.1), or with creatinine clearance <30 ml/ min (OR: 2.2; 95% CI: 1.5–3.4), had an increased incidence of major bleeding. With some variables available at entry we may identify those cancer patients withVTE at a higher risk for recurrences or major bleeding.


2020 ◽  
Vol 2 (3) ◽  
pp. 19-22
Author(s):  
Dilek Kartal ◽  
Azra Arıcı Yurtkul ◽  
Ayşe Rabia Şenkaya

Objective: We aimed to investigate the effectiveness of uterine artery Doppler index and nuchal translucency (NT) measurement in determining perinatal problems in patients diagnosed with hyperemesis gravidarum (HEG). Material and methods: We included 80 pregnant women between the ages of 19–40 years with a singleton, noncomplicated pregnancy, no systemic disease, and no structural and chromosomal disorders in the fetus, who were admitted to our hospital which is a tertiary center with a large patient population in the region, between October 2015 and October 2016 in this study. Further, two group were formed as 40 pregnant women with the diagnosis of HEG (group 1) and 40 pregnant women for control group (group 2). Age, body mass index (BMI), educational status,pregnancy history (live birth, miscarriages), smoking, alcohol consumption, substance use, last menstrual period, serum pregnancy-associated plasma protein A (PAPP-A), free beta-human chorionic gonadotropin, (free ß-hCG), thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4) levels, nuchal translucency (NT), and uterine artery Doppler measurement values were recorded. The data between two groups were compared. Results: The education level of the group 1 was found higher (p = 0.001). The frequency of smoking in group 1 (n = 18; 45%) was found significantly higher than group 2 (n = 3; 7.5%) (p = 0.001). In group 1, uterine artery Doppler pulsatility index (PI) and resistance index (RI) values were found higher than group 2 (p = 0.026 and 0.024, respectively). Conclusion: The uterine artery Doppler PI, RI values measured at 20–24 weeks in patients with HEG were statistically significantly higher than those without HEG.


2020 ◽  
Author(s):  
Yu Liu ◽  
Jing Li ◽  
Yihong Guo

Abstract BackgroundOestradiol, an important hormone in follicular development and endometrial receptivity, is closely related to clinical outcomes of fresh in vitro fertilization-embryo transfer (IVF-ET) cycles. A supraphysiologic E2 level is inevitable during controlled ovarian hyper-stimulation (COH), and its effect on the outcome of IVF-ET is controversial. The aim of this retrospective study is to evaluate the association between elevated serum oestradiol (E2) levels on the day of human chorionic gonadotrophin (hCG) administration and neonatal birthweight after IVF-ET cycles.MethodsThe data of 3659 infertile patients with fresh IVF-ET cycles were analysed retrospectively between August 2009 and February 2017 in First Hospital of Zhengzhou University. Patients were categorized by serum E2 levels on the day of hCG administration into six groups: group 1 (serum E2 levels≤1000 pg/mL, n=230), group 2 (serum E2 levels between 1001 and 2000 pg/mL, n=524), group 3 (serum E2 levels between 2001 and 3000 pg/mL, n=783), group 4 (serum E2 levels between 3001 and 4000 pg/mL, n = 721), group 5 (serum E2 levels between 4001 and 5000 pg/mL, n=548 ), and group 6 (serum E2 levels > 5000 pg/mL, n=852). Univariate linear regression was used to evaluate the independent correlation between each factor and outcome index. Multiple logistic regression was used to adjust for confounding factors.ResultsThe LBW rates were as follows: 3.0% (group 1), 2.9% (group 2), 1.9% (group 3), 2.9% (group 4), and 2.0% (group 6) (P =0.629), respectively. There were no statistically significant differences in the incidences of neonatal LBW among the six groups. We did not detect an association between peak serum E2 level during ovarian stimulation and neonatal birthweight after IVF-ET.ConclusionThe results of this retrospective cohort study showed that serum E2 peak levels during ovarian stimulation were not associated with birth weight during IVF cycles. In addition, no association was found between higher E2 levels and increased LBW risk. Our observations suggest that the hyper-oestrogenic milieu during COS does not seem to have adverse effects on the birthweight of offspring after IVF.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sanghamitra Mohanty ◽  
CHINTAN G TRIVEDI ◽  
Joseph Gallinghouse ◽  
Domenico G Della Rocca ◽  
Carola Gianni ◽  
...  

Background: A considerable proportion of elderly patients are known to have coexistent atrial fibrillation (AF) and amyloidosis. Both conditions increase stroke risk. Objective: We evaluated the best anticoagulation strategy in a series of AF patients with amyloidosis. Methods: Consecutive AF patients with coexistent amyloidosis undergoing catheter ablation at our center were included in the analysis. Based on the stroke-prophylaxis approach they were divided into 2 groups; group 1: left atrial appendage occlusion (LAAO) with Watchman and group 2: oral anticoagulation. Following LAAO, all patients remained on full dose non-vitamin K oral anticoagulants (NOAC) for 45 days. Transesophageal echocardiogram (TEE) was performed at 45 days to assess completeness of closure. If the occlusion was complete, patients were kept on aspirin, 81 mg/day for long-term. In case of leak or dense ‘smoke’ in the left atrium (LA) or enlarged LA, they were prescribed half-dose NOAC. NOACs included dabigatran, apixaban, endoxaban and rivaroxaban. Group 2 patients remained on full-dose NOAC during the whole study period (1 year). All patients were prospectively followed up for 1 year. Results: A total of 87 patients were included in the analysis; group 1: 56 and group 2: 31 . CHA 2 DS 2 -VASc score was comparable between the groups (gr. 1: 3.7±1.6 and gr. 2: 3.2±1.7, p=0.18). The most commonly used NOACs were apixaban (45, 51.7%) and rivaroxaban (34, 39%). After the 45-day TEE, 34 patients from group 1 remained on baby-aspirin and 22 on half-dose NOAC. Of the 22, 12 patients had leaks <5 mm, 6 had large LA (mean diameter 5.2±1.4 cm) and 4 patients had dense LA smoke. At 1-year follow-up, 3 stroke and 1 transient ischemic attack were reported in group 1 on baby-aspirin (4/34, 11.8%). No stroke or bleeding complications occurred in the 22 patients on half-dose NOAC. In group 2 patients on full-dose OAC, a total of 5 (5/31, 16.1%) bleeding events (1 subdural hematoma and 4 GI bleedings) were recorded. Additionally, a stroke was reported that happened during brief discontinuation of OAC for another medical procedure. Conclusion: In our series of patients with coexistent AF and amyloidosis, half-dose NOAC following LAA occlusion procedure was observed to be the safest stroke-prophylaxis strategy.


2018 ◽  
Vol 06 (06) ◽  
pp. E745-E750 ◽  
Author(s):  
J. Gonzalez ◽  
D. Lorenzo ◽  
T. Guilbaud ◽  
T. Bège ◽  
M. Barthet

Abstract Background and study aims Management of post-sleeve gastrectomy fistulas (PSGF) recently has evolved, resulting in prioritization of internal endoscopic drainage (IED). We report our experience with the technique in a tertiary center. Patients and methods This was a single-center, retrospective study of 44 patients whose PSGF was managed with IED, comparing two periods: after 2013 (Group 1; n = 22) when IED was used in first line and before 2013 (Group 2; n = 22) when IED was applied in second line. Demographic data, pre-endoscopic management, characteristics of fistulas, therapeutic modalities and outcomes were recorded and compared between the two groups. The primary endpoint was IED efficacy; the secondary endpoint was a comparison of outcomes depending on the timing of IED in the management strategy. Results The groups were matched in gender (16 female, 16 male), mean age (43 years old), severity of fistula, delay before treatment, and exposure to previous endoscopic or surgical treatments. The overall efficacy rate was 84 % (37/44): 86 % in Group 1 and 82 % in Group 2 (NS). There was one death and one patient who underwent surgery. The median time to healing was 226 ± 750 days (Group 1) vs. 305 ± 300 days (Group 2) (NS), with a median number of endoscopies of 3 ± 6 vs. 4.5 ± 2.4 (NS). There were no differences in number of nasocavity drains and double pigtail stents (DPS), but significantly more metallic stents, complications, and secondary strictures were seen in Group 2. Conclusion IED for management of PSGF is effective in more than 80 % of cases whenever it is used during the therapeutic strategy. This approach should be favored when possible.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 708-708
Author(s):  
Manuel Monreal ◽  
José Nieto ◽  
Ana de Tuesta ◽  
Pablo Marchena ◽  
Gregorio Tiberio ◽  
...  

Abstract Introduction Patients who have experienced a recent major bleeding episode are usually excluded from clinical trials of venous thromboembolism (VTE) treatment. Therefore, recommendations based on evidence from clinical trials of VTE treatment may not be optimal for these patients. The Registro Informatizado de la Enfermedad TromboEmbólica (RIETE), initiated in March 2001, is a multicenter, observational registry gathering data on VTE treatment practices and clinical outcomes in patients with objectively confirmed, symptomatic, acute VTE. The aim of this analysis was to study outcomes in patients with VTE who had experienced major bleeding <30 days prior to VTE diagnosis. Methods Patients with objectively confirmed symptomatic acute VTE are consecutively enrolled into the RIETE registry. Patients are excluded if they are participating in a therapeutic clinical trial or not available for 3-months follow-up. Patient characteristics, details of antithrombotic therapy, and clinical outcomes at 3-months are recorded. Results Of 6361 patients enrolled up to January 2004, 170 (2.7%) had experienced recent major bleeding prior to VTE diagnosis: 69 (40.6%) gastrointestinal tract; 60 (35.3%) intracranial; 41 (24.1%) other. More patients with recent major bleeding had cancer compared with those without recent major bleeding (26.4% vs 20.4%, respectively; p=0.05). More patients who experienced recent major bleeding had undergone surgery <2 months prior to enrollment or had immobility ≥4 days. The incidences of recurrent PE and minor, major, and fatal bleeding complications were also higher in patients who had experienced recent major bleeding (table 1). Patients with recent major bleeding and cancer had an increased incidence of major bleeding compared to those without cancer (20.0% vs. 2.4%, respectively; OR 10.0; 95% CI 2.3–50.0; p<0.001); 11.0% of patients who had recent major bleeding prior to VTE diagnosis and cancer experienced fatal PE compared with none in patients who had recent major bleeding but without cancer (OR 4.1; 95% CI 4.98–17; p<0.05). Conclusion Patients with VTE and recent major bleeding prior to VTE diagnosis (2.7% of total enrolled patients) had poorer clinical outcomes, in terms of bleeding complications, fatal PE and overall mortality compared with those who had not experienced recent major bleeding. In patients who had recent major bleeding prior to VTE diagnosis, those with cancer had a poorer clinical outcome than those without cancer. Table 1. Clinical outcome of enrolled patients 3-month outcome Recent major bleeding No recent major bleeding OR (95% CI) p value n (%) n=170 n=6191 Fatal bleeding 7 (4.1) 41 (0.6) 6.4 (2.6-15) <0.001 Major bleeding 12 (7.1) 146 (2.3) 3.1 (1.6-5.9) 0.001 Minor bleeding 12 (7.1) 172 (2.8) 2.6 (1.4-5.0) <0.005 Fatal (initial) PE 1 (0.6) 14 (0.2) 2.6 (0.2-19) NS Fatal (recurrent) PE 4 (2.4) 33 (0.5) 4.5 (1.3-14) <0.05 Recurrent VTE 8 (4.7) 184 (2.9) 1.6 (0.7-3.4) NS Overall mortality 25 (15.0) 479 (7.7) 2.1 (1.3-3.2) <0.005


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4364-4364
Author(s):  
Shabnam Zolfaghari ◽  
Svetlana Marx ◽  
Jeelka Fischer ◽  
Parastoo Hassani ◽  
Marinella Damian ◽  
...  

Abstract Abstract 4364 Anticoagulation with dose adjusted vitamin-K antagonists (VKA, therapeutic range of the international normalized ratio (INR) of 2 to 3) and low dose aspirin (65 to 330 mg daily) enhance bleeding following tooth extraction. However, intensity of bleeding varies substantially between patients. Guidelines disagree regarding interruption or continuation of anticoagulation for tooth extraction. We hypothesized that personality traits may moderate bleeding intensity under anticoagulation. A total of 180 patients (77 female, 103 male, 49.9+15.3 years (mean, standard deviation)) underwent tooth extraction without interruption of anticoagulation. Sixty three patients did not take any anticoagulant (group 1), 60 patients were on aspirin (group 2), and 57 patients on VKA (INR 2–3, group 3). Patients completed a validated state-trait anxiety inventory (STAI), a personality inventory with 12 dimensions (Freiburg personality inventory (FPI)), and a self-developed questionnaire on general attitudes regarding general feeling and anxiety before tooth extraction. Dentists (JF, PH) rated bleeding intensity ranging from 0 to 9 according a standardized protocol. Intensity of bleeding after tooth extraction was higher in group 3 (score <5 in 40%, score >5 in 60% of patients) compared to groups 1 (40% and 60%) and 2 (53% and 47%) and higher in group 2 compared to group 1 (p<0.005, chi-square test) as expected. Higher anxiety values in STAI questionnaire correlated positively with higher bleeding scores (p<0.0001). High values of some of the FPI dimensions correlated positively with self-consciousness (p<0.0001), physical complaints (p<0.001), and emotionality (p<0.0001) life, and negatively with satisfaction (p<0.02) and extraversion (p<0.003) without differences between groups 1 to 3. Anxiety symptoms of the self questionnaire were identified as moderating factor on bleeding intensity following tooth extraction independently of anticoagulation (p<0.0001) according multinominal regression analysis. Other items of the self questionnaire such as physiological stress symptoms, regular performance of visits, bad experience with dentists, and pains during tooth extraction did not influence bleeding intensity. A short questionnaire is developed to identify the anxiety score of patients as a tool for a non pharmaceutical medical intervention to reduce bleeding complications following tooth extraction. Because differences of the moderating effect of bleeding by personality traits may exist between cultures, the questionnaire will be made available across countries www.blutverduennung.uni-hd.de Disclosures: No relevant conflicts of interest to declare.


2017 ◽  
Vol 44 (04) ◽  
pp. 348-352 ◽  
Author(s):  
Reinhard Raggam ◽  
Franz Hafner ◽  
Alexander Avian ◽  
Gerald Hackl ◽  
Gerhard Cvirn ◽  
...  

AbstractThe aim of this study was prospective evaluation of the performance of the HAS-BLED score in predicting major bleeding complications in a real-world outpatient cohort, during long-term anticoagulation for venous thromboembolism (VTE), treated with a broad spectrum of anticoagulants. We analyzed 111 outpatients objectively diagnosed with VTE and treated long-term with various anticoagulants. Patients were grouped in three cohorts based on the anticoagulant regimen. Calculation of the HAS-BLED score and documentation of bleeding events were performed every 6 months for 1 year. Patients with a HAS-BLED score ≥ 3 had an increased risk for major bleeding events (odds ratio [OR]: 13.05, 95% confidence interval [CI]: 0.96–692.58, p = 0.028) and a trend to higher risk for minor bleeding events as well (OR: 2.25, 95% CI: 0.87–5.85, p = 0.091) when compared with patients with a HAS-BLED score < 3.This indicates that a HAS-BLED score ≥ 3 allows for identification of patients with VTE on long-term anticoagulation at an increased risk for major bleeding events, irrespective of the anticoagulant agent used.


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