BACKGROUND: Endovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered stents have exhibited enhanced clinical outcomes compared with bare metal stents. However, there is currently a lack of level I evidence comparing the safety and efficacy of paclitaxel-eluting stents and heparin-bonded covered stents. Therefore, the primary objective of this study is to systematically evaluate the efficacy and safety outcomes of these two types of stents.
METHODS: The ELITE trial is a prospective, multicentre, parallel, randomised controlled trial. A total of 450 patients will be recruited. The primary endpoints of the study include primary patency at 1 year post-index procedure.
BACKGROUND: Ethical approval for this study was obtained from the Ethics Committee of West China Hospital of Sichuan University (approval number: 2023-1186). The results will be submitted to a major clinical journal for peer review and publication.
BACKGROUND: ELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).

UNASSIGNED: Pregnant women manifest an increased risk of developing coagulation disorders. Unfractionated heparin (HEP) and low-molecular-weight heparin (LMWHep) are considered as selective medication in the case of pregnancy which needs anticoagulant treatment. In addition to anticoagulant properties, HEP and its derivatives manifest other properties including anti-cancer potential. According to Globocan\'s latest data, colorectal cancer (CRC) is the second most encountered form of malignancy in the case of women, manifesting some special particularities, as confusion of symptoms from cancer with symptoms encountered normally in pregnant women (such as constipation or rectal bleeding), delayed diagnosis because of limitations imposed both for the fetus and for the mother, and the need for special treatment.
UNASSIGNED: The aim of the present work is to follow the incidence and safety of consumption of HEP and LMWHep in the case of pregnant women and to analyze their potential on the HCT 116 colorectal carcinoma cells.
UNASSIGNED: Analyzing the consumption of heparins in case of pregnant women hospitalized from 01.01.2022 to 31.12.2022 at the Pius Brînzeu\" Emergency Clinical Hospital from Timisoara, Obstetrics and Gynecology Clinic I, it was observed that 44,6% of the patients were administered the following medication and no administration risks were observed. When tested on HCT 116 cells, heparins manifested a significant anti-migratory effect (with wound healing rates of 2,6%, when tested with HEP 100 UI concentration and 14.52% wound healing rates in case of fraxiparine 100 UI). In addition, different signs of apoptosis were observed, suggesting the pro-apoptotic potential of the tested substances.
UNASSIGNED: Heparins remain the preferred medication to be administered to pregnant women with the potential for coagulation disorders, showing a high safety profile. Testing on the cancerous line of colorectal carcinoma highlights important properties that stimulate future studies, to establish the anti-tumor potential and the exact mechanism of action.

OBJECTIVE: The present meta-analysis focused on investigating whether bivalirudin plus post-PCI infusion was safer and more effective than heparin monotherapy in patients who developed ST-segment elevation myocardial infarction (STEMI) and who underwent primary percutaneous coronary intervention (PCI).
METHODS: The PubMed, EMBASE, Cochrane Library, and Web of Science databases were systemically searched to identify randomized controlled trials (RCTs) comparing bivalirudin and heparin for treating STEMI patients who underwent primary PCI. The Cochrane quality assessment tool was used to assess the quality of the enrolled studies. The primary and secondary outcomes included net adverse clinical events (NACEs, comprising all-cause death or major bleeding), major adverse cardiovascular events (MACEs, comprising all-cause death, stroke, MI, and TVR), in-stent thrombosis (IST), and bleeding of Bleeding Academic Research Consortium (BARC) types 2, 3, and 5.
RESULTS: The four RCTs, comprising 10,695 events, included 5350 patients who received bivalirudin combined with post-PCI infusion and 5345 patients who received heparin monotherapy. Compared with those in the heparin group, the number of NACEs (RR 0.84, 95% CI 0.73-0.96, P = 0.009), MACEs (RR 0.82, 95% CI 0.67-0.99, P = 0.04), and ISTs (RR 0.66, 95% CI 0.49-0.91, P < 0.0001) in the bivalirudin group was significantly lower. There were no significant differences in all-cause death, cardiac death, stroke, MI, TVR, or BARC type 2, 3, or 5 bleeding between the two groups.
CONCLUSIONS: In STEMI patients undergoing primary PCI, bivalirudin plus post-PCI infusion significantly reduced the incidence of NACEs, MACEs, and ISTs compared with heparin monotherapy, without increasing the risk of MI or TVR. Bivalirudin may also contribute to a potential reduction in stroke, death, and BARC type 2, 3, and 5 bleeding rates.

UNASSIGNED: Renal failure is one of the most common chronic complications of diabetes. Simultaneous pancreas-kidney transplantation (SPK) is considered the preferred treatment for individuals with diabetes and chronic renal failure. This procedure has demonstrated efficacy in enhancing the quality of life for patients and minimizing the complications associated with diabetes.
UNASSIGNED: In this study, we analyzed the incidence and safety of complications in different thrombosis prevention techniques post simultaneous pancreas-kidney transplantation (SPK).
UNASSIGNED: Patients who underwent SPK between January 2019 and December 2022 were selectively categorized into two groups: the heparin group and the non-heparin group depending on the utilization of low molecular weight heparin. The occurrence of complications and clinical outcomes were subsequently calculated in each group.
UNASSIGNED: In this study, we included a total of 58 recipients who underwent SPK, with 36 in the heparin group and 22 in the non-heparin group. Among the 58 participants, there were 3 cases of pancreatic thrombosis complications, with 2 cases (5.6%) in the heparin group and 1 case (4.6%) in the non-heparin group, and the differences were not statistically significant (P> 0.05). Regarding gastrointestinal bleeding, there were 17 cases out of the total 58 patients, with 14 cases (38.9%) in the heparin group and 3 cases (13.6%) in the non-heparin group, and the difference was statistically significant (P< 0.05).
UNASSIGNED: After surgery, the use of low molecular weight heparin anticoagulation may increase the likelihood of experiencing gastrointestinal bleeding. Prior to the surgery, a comprehensive evaluation of the coagulation status and medical history of the patient should be performed, enabling stratification of risks involved. Based on this assessment, either low-molecular-weight heparin or aspirin should be selected as a preventive measure against thrombosis.

BACKGROUND The transradial approach (TRA) for cerebral angiography and neurointerventional treatment has gained popularity, but the narrow diameter and weak pulsation of the radial artery lower the initial puncture success rate compared to femoral artery puncture. This retrospective study from a single center evaluated the incidence of and factors associated with radial artery occlusion (RAO) in 543 patients who underwent transradial approach (TRA) for cerebral angiography. MATERIAL AND METHODS We included 543 patients who underwent TRA from July 2021 to February 2024. Ultrasound was used to determine whether the radial artery was occluded. Relevant clinical data were recorded to assess the incidence of and factors affecting RAO. RESULTS At 24 h after DSA, we performed ultrasound imaging. The patients were divided into an RAO group (n=32) and a non-RAO group (n=511). Results showed that RAO was significantly higher in patients who did not have add heparin to the antispasmodic agents, and they were more likely to have needed more than 3 radial artery puncture attempts, and tended to have received an 11-cm radial artery sheath with the Cordis puncture needles (all P<0.05). Multiple regression logistic analysis showed that adding heparin to the antispasmodic agents (OR=0.076, 95% CI: 0.018-0.321, P<0.001), having fewer than 3 radial artery puncture attempts (OR=0.245, 95% CI: 0.111-0.541, P<0.001), using a 16-cm radial artery sheath (OR=0.195, 95% CI: 0.067-0.564, P=0.003), and using Terumo puncture needles (OR=0.325, 95% CI: 0.148-0.717, P=0.005) can reduce the incidence of radial artery occlusion. CONCLUSIONS Our center found that adding heparin to the antispasmodic agents reduced the number of radial artery punctures attempts, and using a 16-cm radial artery sheath significantly lowered the incidence of early RAO after transradial cerebral angiography.

UNASSIGNED: Cardiac surgery is a high-risk setting for heparin-induced thrombocytopenia (HIT). However, large differences in its incidence, rate of thrombotic complications, and mortality have been reported in this context. Few studies address the pharmacologic management of HIT specifically in this setting.
UNASSIGNED: To describe the incidence, outcomes, and management of patients with HIT in our cohort and to compare them with patients presenting platelet factor 4/heparin antibodies but without platelet-activating capacity.
UNASSIGNED: A retrospective observational study was conducted over a period of 10 years and 6 months on 13,178 cardiac operations in a single high-volume cardiac surgery center.
UNASSIGNED: HIT was diagnosed in 0.22% of patients. HIT with associated thromboembolic complications occurred in 0.04% of cases. Two deaths at 30 days were registered, both in patients with associated thrombosis. The 4T score showed a 99.9% negative predictive value. The immunoglobulin G-specific chemiluminescence test positivity rate was highly predictive of HIT. Warfarin was often started early after surgery, and although it was rarely stopped when the diagnosis of HIT was made, no new thromboembolic complications subsequently occurred. Thrombocytopenia appeared to be a poor prognostic sign, whatever the cause.
UNASSIGNED: Although rare, HIT is characterized by high mortality in this setting, especially if thrombotic complications occur. Large multicentric studies or an international registry should be created to enhance the scientific evidence on HIT diagnosis and management in this context.

BACKGROUND: The 2021 Surviving Sepsis Campaign guidelines recommend low-molecular-weight heparin for the prevention of venous thromboembolism in sepsis. However, observational studies suggest that anticoagulants as a whole may benefit severely ill sepsis patients with coagulopathy, but the optimal targets of unfractionated heparin remain unclear. This study investigated which sepsis patients could most benefit from unfractionated heparin.
METHODS: In this retrospective observational study, we identified adult sepsis patients requiring urgent hospitalization from 2006 to 2019 using a large-scale Japanese medical database. Patients were divided into two groups: those receiving unfractionated heparin within 72 h of admission and those who did not. We compared in-hospital mortality, major bleeding complications, and thromboembolic events between these groups using a multivariate logistic regression model adjusted for patient and treatment variables. Additionally, we assessed the association between heparin administration and in-hospital mortality across various subgroups.
RESULTS: Among 30,342 sepsis patients, 2520 received early heparin administration, and 27,822 did not. Multivariate logistic regression revealed a significant association between heparin and reduced in-hospital mortality (adjusted OR: 0.735, 95 % CI: 0.596-0.903) but no significant association with major bleeding and thromboembolic risk (adjusted OR: 1.137, 1.243; 95 % CI: 0.926-1.391, 0.853-1.788, respectively). Subgroup analyses suggested significant survival benefits associated with heparin only in the sepsis patients with moderate coagulopathy and sepsis-induced coagulopathy scores of 3 or 4 (adjusted OR: 0.452, 0.625; 95 % CI: 0.265-0.751, 0.410-0.940, respectively).
CONCLUSIONS: Early heparin administration upon admission is associated with lower in-hospital mortality, especially in moderate sepsis-induced coagulopathy, and no significant increase in complications.

BACKGROUND: Central venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock.
METHODS: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers.
BACKGROUND: Ethics approval has been provided by Children\'s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences.
BACKGROUND: ACTRN12622000499785.

BACKGROUND: The heparin sensitivity index (HSI) is closely associated with perioperative ischemic events and increased blood loss in cardiac surgery. Previous studies have produced conflicting results. Therefore, this study aimed to investigate the relationship between HSI and postoperative blood loss specifically in Chinese patients undergoing elective off-pump coronary artery bypass grafting (OPCAB).
METHODS: Patients underwent OPCAB between March 2021 and July 2022 were retrospectively included. Enrolled patients were classified into Low-HSI (HSILOW; HSI < 1.3) and Normal-HSI (HSINORM; HSI ≥ 1.3) groups. HSI = [(activated clotting time (ACT) after heparin) - (baseline ACT)] / [loading dose of heparin (IU/kg)]. Primary outcome included postoperative blood loss at 24 h. Secondary outcomes were total postoperative blood loss, transfusion requirement of red blood cell (RBC), fresh frozen plasma (FFP), platelet concentrates (PC), and other complications.
RESULTS: We retrospectively analyzed 303 Chinese OPCAB patients. HSILOW group had higher preoperative platelet (PLT) count (221 × 109/L vs. 202 × 109/L; P = 0.041) and platelet crit (PCT) value (0.23% vs. 0.22%; P = 0.040) compared to HSINORM group. Two groups showed no significant differences in postoperative blood loss at 24 h (460 mL vs. 470 mL; P = 0.252), total blood loss (920 mL vs. 980 mL; P = 0.063), RBC transfusion requirement (3.4% vs. 3.1%; P = 1.000), FFP transfusion requirement (3.4% vs. 6.2%; P = 0.380), and other complications. Preoperative high PLT count was associated with low intraoperative HSI value (odds ratio: 1.006; 95% confidence interval: 1.002, 1.011; P = 0.008).
CONCLUSIONS: Intraoperative HSI value was not associated with postoperative blood loss in Chinese patients undergoing OPCAB. Preoperative high PLT count was an independent predictor of low intraoperative HSI value.

OBJECTIVE: There are conflicting results in preventing catheter-related thrombosis (CRT). Continuing infusion of unfractionated heparin (UFH) was a potential option for CRT. This study was to determine the effect of continuous UFH infusion on asymptomatic CRT at discharge in infants after cardiac surgery.
METHODS: This study was a randomized, placebo-controlled, clinical trial at a single center. All infants with central venous catheters after cardiac surgery, below 3 months of age, were eligible. Stratified by CRT, infants were randomly assigned to the UFH group or the normal saline group. UFH was initiated at a speed of 10 to 15 units/kg/h for infants with CRT and 2 to 3 units/kg/h without CRT. The primary outcome was to determine the rate of CRT at discharge. The secondary outcomes included thrombosis 6 months after surgery, adverse events of UFH, and post-thrombotic symptoms.
RESULTS: Due to slow recruitment during the COVID-19 pandemic, this trial was prematurely stopped. Only 35 infants were randomly assigned to the UFH or control groups. There was no statistically significant difference in CRT rate at discharge ( P =0.429) and 6 months after surgery ( P =1.000) between groups. All CRTs except one disappeared at discharge. No thrombosis or post-thrombotic symptom was reported at follow-up evaluation. There was no difference between groups in duration of thrombus ( P =0.088), D dimer ( P =0.412), catheter in situ days ( P =0.281), and post-thrombotic syndrome ( P =1.000), except for activated partial thromboplastin time ( P =0.001).
CONCLUSIONS: With the early stop of this trial and limited data, it is difficult to draw a definitive conclusion about the efficacy of UFH on CRT. Meanwhile, considering the data from 6 months follow-up, in this population, asymptomatic CRT might resolve with no intervention.