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Showing 1-20 of 33 trials
NCT06664788
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.
NCT07466719
The goal of this clinical trial is to compare the safety and efficacy of manual syringing versus pneumatic pressure bags for blood transfusion in patients experiencing major obstetric hemorrhage during a cesarean section. It will also evaluate the effectiveness of these methods in rapidly stabilizing patient vital signs. The main questions it aims to answer are:Does manual syringing result in a higher incidence of hemolysis (red blood cell destruction) compared to pneumatic pressure bags?Which method is more effective and faster at achieving hemodynamic stability (restoring normal blood pressure, heart rate, and oxygen levels)?Are there differences between the two methods regarding total blood product usage, transfusion-related complications, and the length of hospital stay?Researchers will compare manual syringing (using 20 mL syringes) to pneumatic pressure bags (inflated to 300 mmHg) to determine which is safer and more efficient for emergency transfusions in resource-constrained environments.Participants will:Be women aged 18-45 years undergoing a cesarean section who are diagnosed with major obstetric hemorrhage (blood loss \>1000 mL or hemodynamic instability).Be randomly assigned to one of two groups to receive their blood transfusion through either the manual syringe method or a pneumatic pressure bag.Receive standard vascular access through multiple peripheral and jugular cannulae.Undergo close monitoring of vital signs to determine the time to stabilization.Provide blood samples at baseline and six hours post-transfusion to measure markers of hemolysis, specifically Lactate Dehydrogenase (LDH) and indirect bilirubin levels.Be monitored for any transfusion-related complications, such as allergic reactions or acute kidney injury, during their hospital stay and for major complications up to 30 days postoperatively
NCT07349251
This study aims to retrospectively determine, in a large cohort of apparently healthy children born before 37 weeks of gestation, the expected values of certain hemostasis parameters from birth to 18 months (when they start walking), and to determine whether or not they differ from those of full-term infants.
NCT06450834
In spine surgery, it is important to try to minimize bleeding. In particular, spine surgery often involves inserting hardware into bone, and/or removing bone in the spine. Because the bone in the spine contains blood vessels, there can often be bleeding from the bone itself that is difficult to stop completely. One way to stop bone bleeding is through the use of wax-like materials, which plug the bleeding bone and act as a physical barrier to stop bleeding. One example is Ostene bone hemostasis material, which has the advantage of being "water soluble", meaning it will dissolve naturally over time. The purpose of this study is to evaluate how well Ostene does at decreasing bleeding, by using a recognized scale called the validated intraoperative bleeding severity scale, abbreviated as "VIBe". In this study, the investigators will record the bleeding severity throughout multiple time points in surgery using this scale, and then the investigators will compare the measurements to patients in the past who did not receive Ostene. Overall, this research will help measure how well Ostene decreases bleeding.
NCT05822804
The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.
NCT06415760
This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy
NCT07013955
The goal of this interventional study is to compare the nasal packing with dexmedetomidine .midazolam or bupivacaine on surgical field visualization during FESS . Study groups : Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline. Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline. Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
NCT06934096
This is a three-cohort, randomized, double-blinded , sham-controlled, single-center, early feasibility research trial to determine whether organ-specific biologic effects on platelet activity and coagulation are achievable through selective ultrasound of the spleen utilizing low-energy (diagnostic-level) insonification. * Group 1: Focused insonification at center of the spleen. * Group 2: Prolonged duration insonification at center of the spleen * Group 3: Prolonged duration insonification across the spleen. Participants will receive 30 minutes of sham stimulation in the randomized group that is assigned to them, followed by active stimulation within the same group. Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device
NCT05977946
This study is designed as a randomized, double-blind, sham-controlled, single-center research study in which healthy adults will be randomized 1:1 into one of two experimental groups, to receive transcutaneous auricular vagus nerve stimulation (taVNS) targeting either the auricular branch of the vagus nerve (ABVN) or tAN, which targets the ABVN and the auriculotemporal nerve (ATN): 1. Group 1: Sham taVNS followed by active taVNS 2. Group 2: Sham tAN followed by active tAN Participants will receive 30 minutes of sham stimulation (taVNS or tAN), followed by active stimulation (taVNS or tAN). Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device.
NCT04456894
Lung transplantation is a very long and difficult procedure accompanied by a number of possible complications. In the vast majority of cases, the operation itself is performed using the ECMO support, which can negatively affect blood clotting, especially the formation of a platelet blood clot, i.e. primary hemostasis. Thus, the procedure may be accompanied by considerable blood loss, which amount can subsequently negatively affect the postoperative period. It can be assumed, that precise diagnosis of primary hemostasis disorders and subsequent targeted therapy can reduce blood loss and improve outcome of the patient. However, the role of primary hemostasis has not yet been sufficiently specified in this area. Usually, coagulation functions during surgery, are at our department monitored by using ROTEM tests (assesses clot strength), PFA 200 (assesses primary haemostasis under high shear stress conditions and is very sensitive to vWF deficiency) and ROTEM / platelet (assesses primary haemostasis under "low shear stress" conditions and is very susceptible to platelet dysfunction). Targeted therapy by administering necessary clotting factors is used, if any pathology in these tests is detected. However, it is not known, whether the targeted therapy administered is effective enough in patients during the support of extracorporeal circulation. In our monocentric, prospective, observational study, data from the tests mentioned above will be analyzed, and their correlation with a laboratory examination of VWF levels and activity will be monitored. Based on these data, we will try to determine whether perioperative examination of primary hemostasis during lung transplantation (PFA examination, Rotem / platelet-aggregometry and von Willebrand factor-vWF level) is of clinical significance and whether the diagnosis of hemostasis disorder at this level and subsequent targeted therapy may reduce perioperative blood loss.
NCT04857385
RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization. A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices. Follow-up of the subject will take place 60 days after the index procedure.
NCT05511675
According to the World Health Organization data, approximately 17.9 million people die every year due to heart disease. 85% of these deaths are due to heart attack and blocked blood vessels. The Turkish Statistical Institute reports that circulatory system diseases took the first place among the causes of death with 38.4%, while ischemic heart diseases constituted 39.7% of these deaths in 2018. Transradial angiography is used for the purpose of scanning and treatment of coronary arteries both in Turkey and in other countries of the world. Aim: After transradial angiography, Terumo (TR) band is used as a common device which is provides pneumatical hemostasis. This study aims to reduce usage time of the TR band, a decrease of hematoma formation and a reduction in the level of extremities pain experienced as a result of transradial angiography, thanks to using the TR band together with cold application.
NCT06212635
Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.
NCT06199414
Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.
NCT06166940
Sixty consecutive newborn patients who underwent pediatric cardiac surgery from April 2022 to October 2023 at Basaksehir Cam and Sakura City Hospital) were included in this study. Data of eighty-six patients who received ROTEM guided transfusions after August 15, 2022 was collected. First sixteen patients were given cryoprecipitate in the middle of the Modified ultra-filtration (MUF) procedure according to previous conventional approach, and so these patients excluded. And ten patients were excluded due to the lack of information. Thirty patients, who received ROTEM guided transfusions compared to the prior thirty patients who received transfusions conventionally. There was no randomization and standardized anesthesia and surgical techniques were used. Anesthesia induction conducted with midazolam, ketamine, fentanyl, and rocuronium bromide; and antifibrinolytic (tranexamic acid) infusion was used during operation till the closure of skin. Anesthesia and cardiopulmonary bypass(CPB) anesthesia was maintained with remifentanil, midazolam, ketamine and rocuronium, and sevoflurane -not during bypass. Size-adapted bypass circuits and membrane oxygenators (FX05 oxygenators) were used. Total priming volume for the bypass circuit was 250 - 400 ml, consisting of red blood cell (RBC), fresh frozen plasma (FFP), Isolyte-S solution, mannitol, sodium bicarbonate, tranexamic acid, prednisol, and antibiotic. Anticoagulation during CPB was managed with 350 U/kg unfractioned heparin (Novo-Heparin) and additional boluses of 50 U/kg, as needed, to maintain an activated clotting time (ACT) of at least 450s. Heparin anticoagulation was antagonized with 3,5 mg/kg protamine. Red blood cell concentrates were transfused to maintain the haematocrit at 28 - 32% during cardiopulmonary bypass (CPB). Bypass was conducted under mild (core temperature 32°C ) and moderate (core temperature 28 °C) hypothermia. Myocardial protection was achieved with cold intermittent blood cardioplegia (20 ml/kg), which was prepared during CPB by adding buffered del nido solution (Plasma-Lyte A) in the ratio 1:4 to whole blood obtained from the arterial line. The cardioplegia solution was kept at 6°C before infusion. Blood sample for running ROTEM analysis were taken just before weaning CPB, when the core temperature of patients were 36-37 °C. MUF was performed after weaning from CPB and 5-10 minutes before protamine administration, with a target haematocrit of 35-40%. After heparin antagonization, RBC transfusions applied with a target haematocrit of 35-40 % for non-cyanotic patients, and 40-45% for cyanotic patients. We collected data on the following subject characteristics: height (cm); weight (kg); age (days); gender; presence of cyanosis; presence of ay genetic disorder; Aristotle score (1,5-25); duration of the surgical procedure (min); CPB time (min); aortic cross clamp time (min); the lowest core temperature during CPB; total amount of blood products transfused after CPB intraoperatively (ml/kg), including red blood cell concentrates, FFP, platelet concentrates, cryoprecipitate, and fibrinogen concentrates; total amount of blood products transfused after operation up to 24 h after admission to the Pediatric Cardiac Intensive Care Unit (PCICU) (ml/kg); total amount of chest tube drainage after operation up to 24 h after PCICU admission (ml/kg); 28 day survival; extracorporeal membrane oxygenator (ECMO) application; and need for peritoneal dialysis. In all patients, routine blood samples for hemoglobin (Hb), haematocrit (Hct), prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), platelet count; renal function tests urea and creatinine were collected preoperatively. Hb, Hct, PT, INR, aPTT, platelet count, urea and creatinine were also analyzed on the first postoperative morning. We conducted thromboelastometry in the operating theatre (OR) using the ROTEM device. Four assays-EXTEM, INTEM, FIBTEM, and HEPTEM were tested in citrated whole blood. Because the patients were still under heparin effect when the samples were taken, we made transfusion adjustments according to EXTEM and FIBTEM test results. Since we got the EXTEM, FIBTEM A5 results as soon as heparin antagonization was complete, we transfused the blood products according to the results. We also collected those data. The primary outcome was the proportion of perioperative transfusion (intraoperatively and in the PCICU) in the ROTEM group and in the conventional group. The secondary outcomes are postoperative chest tube drainage up to 24 hours; need for peritoneal dialysis. The other analyses have mainly a descriptive purpose.
NCT04268992
Introduction: Regular exercise training improves prognosis in patients with coronary artery disease (CAD). This study investigates whether the beneficial effects of exercise can be partly explained by favourable changes in haemostasis and inflammation. Methods: 150 CAD patients are randomised to a supervised long-term exercise program (3 months) or usual care. Blood samples are obtained at baseline, 1.5 months, and 3 months after randomisation. Results: The investigators will evaluate platelet turnover and aggregation, coagulation, fibrinolysis, and inflammatory markers before and after short- and long-term exercise, and the two randomised groups will be compared. Perspectives: The present study will increase our knowledge of the beneficial mechanisms underlying the effect of exercise in CAD patients, potentially paving the way for improved exercise recommendations.
NCT04459871
A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.
NCT05027698
The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site. This study is conducted in real-world subjects according to the FemoSeal™ VCS instruction for use (IFU), as part of the study device post-market clinical follow up surveillance plan and prospective clinical evidence collection.
NCT04415606
QuikClot Control+ Hemostatic Dressing (QuikClot+) is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV Bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. QuikClot Control+ is also indicated for temporary control of mild to moderate bleeding in cardiac surgical procedures. QuikClot Control+ is also indicated for use to control bleeding from bone surface following sternotomy.
NCT03699670
A lesion work-up associating clinical examination, extended focused ultrasound (eFAST including abdominal ultrasound \[right upper, left upper, and suprapubic quadrant\], bilateral anterior and lateral pleuropulmonary ultrasound, sub-xyphoid pericardial ultrasound, transcranial Doppler), and possibly chest and pelvis x-ray, can early diagnose the most severe traumatic lesions and guide first aid resuscitation and haemostasis. The protocol does not modify the diagnostic and therapeutic strategies applied in the participant centers. The objective of the study is to evaluate the diagnosis performance of an initial lesion assessment by extended focused ultrasound (eFAST) (possibly associated with chest and pelvis x-ray) at the early phase of a severe trauma patient care in guiding first aid resuscitation and haemostasis. The relevance will be judged on the therapeutic decisions taken (thoracic or pericardial drainage, thoracotomy or laparotomy, pelvic embolization, posture of a pelvic girdle, and early optimization of cerebral perfusion pressure) based on the initial ultrasound scan.