TIPS Plus Transvenous Obliteration for Gastric Varices
CirrhosisLiver5 moreVariceal hemorrhage (VH) from gastric varices (GVs) results in significant morbidity and mortality among patients with liver cirrhosis. In cases of acute bleeding, refractory bleeding, or high risk GVs, the transjugular intrahepatic portosystemic shunt (TIPS) creation and transvenous variceal obliteration procedures have used to treat GVs. While these techniques are effective, each is associated with limitations, including non-trivial rebleeding and hepatic encephalopathy rates for TIPS and aggravation of esophageal varices, development of new or worsening ascites, and formation of difficult to treat ectopic varices for transvenous obliteration. Increasingly, however, TIPS and transvenous obliteration are viewed as complimentary procedures that can be combined to reduce bleeding risk and ameliorate sequelae of portal hypertension. Yet, despite a strong mechanistic basis for their combination, there are few studies investigating the combined effectiveness of TIPS plus transvenous obliteration. Thus, the aim of this single center prospective pilot study is to assess the effectiveness and safety of combined TIPS creation plus transvenous obliteration for the treatment of GVs, with the overall goal of improving the clinical outcomes of patients with VH related to GVs. The work proposed could lead to important advances in the treatment of bleeding complications due to liver cirrhosis.
Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users
Abnormal Uterine BleedingTranexamic Acid2 moreAbnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA
MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated,...
Intracerebral HemorrhageCAA - Cerebral Amyloid Angiopathy1 moreThis is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.
Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
Intracerebral HemorrhageIntracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.
Efficacy of Continuous Terlipressin Therapy After Endoscopic Variceal Ligation
Variceal HemorrhageUpper gastrointestinal (UGI) bleed of variceal origin is a common medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic. Terlipressin, a vasopressin analog (intravenous, 2 mg q 4 hourly), is widely used promptly in any suspicious cases of variceal haemorrhage (VH) before endoscopic intervention, along with volume and blood resuscitative measures. As per guideline, after EVL Terlipressin therapy (1 mg IV q 4 hourly) is advised to continue for 2-5 day to prevent re-bleed and mortality [1]. But the prolong use of Terlipressin is not completely safe as well as it is expensive also in resource constraint setting. At present, no randomized control clinical trial (RCT) is available to prove the efficacy of post-EVL Terlipressin therapy in preventing re-bleed and mortality in acute variceal haemorrhage. During the post marketing surveillance Terlipressin therapy was found to be associated with life threatening complication like cardiac arrhythmia, myocardial ischemia, critical vasoconstriction of peripheral as well as internal organ leading to ischemia or gangrene, severe hyponatremia, hypertension, fluid overload and pulmonary oedema (2-4). So the justification of continuing Terlipressin for 5 days after EVL is questionable, as the haemostasis is primarily achieved by EVL and the risk versus benefit of Trelipressin therapy after EVL is still unknown. Continue IV Terlipressin therapy also prolongs in-hospital care causing further increase of health care burden. As per recently concluded institutional study, continuing Terlipressin after EVL in acute VH did not prevent re-bleed or mortality, rather it increased the risk of ADR, duration of hospital stay, in-hospital complications and cost of the therapy [5]. But the study was open level with relatively smaller sample size. There is still lack of RCT on post-EVL Terlipressin therapy, regarding its efficacy in preventing re-bleed and mortality. So, we have planned this study to evaluate the efficacy of continuous Terlipressin therapy after EVL, in acute VH. It will be a double blind randomized controlled clinical trial. The study will be carried out in the 2 arms; denoting the duration of Terlipressin therapy after EVL. Participant with acute VH will be randomized into two study groups after successful EVL. The treatment group will receive injection Terlipressin (1 mg IV bolus q 4 hourly) for 2 days and the control group will receive 10 ml of 0.9% normal saline (NS) IV bolus q 4 hourly instead of Terlipressin for 2 days. Both the group will receive standard care of therapy and will be followed up for 8 weeks. The participants and the recruiter/PI will be unaware of intervention (terlipressin or NS) receiving. The study will enlighten us regarding efficacy of continuous Terlipressin therapy after EVL to prevent re- bleed and mortality in acute VH. The study will also generate significant data regarding adverse drug events (ADE) and cost effectiveness or pharmaco- economics of continue Terlipressin therapy after EVL. In the Indian population there is no study to determine the role gene related to variceal bleed or re-bleed. Endothelial dysfunction is the major contributor for the development of portal hypertension and subsequent varices formation in patient with cirrhosis. Development of blood vessel and endothelial function, endothelial proliferation and neoangiogenesis are regulated by vascular endothelial growth factor (VEGF) family genes. In a recently published study, VEGF C(+405)G(rs2010963) single nucleotide polymorphism (SNP) genotype was found to be associated with higher risk of esophageal and gastric varices and bleeding [10]. Since VEGF is the major factor to endothelial proliferation and neoangiogenesis. So, in this study, as a secondary objective, we will also try to explore the association of VEGF genotype with variceal bleed/ re-bleed and mortality.
Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery
Postoperative HemorrhageThe primary aim of this study is to observe the effects of two different methods of administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively in cardiovascular surgery, on patients' postoperative bleeding amounts. According to the hypothesis established in this study, it is anticipated that administering tranexamic acid as an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable blood level compared to the sole i.v. bolus application, thereby being more effective in influencing postoperative bleeding levels. The study has been designed as a prospective observational research. The outcomes of two different tranexamic acid protocols applied during cardiovascular surgical procedures will be compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration. The cases collected over a period of 6 months will be divided into two groups and compared in terms of intraoperative and postoperative bleeding levels, as well as their need for blood products.
Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
Subarachnoid HemorrhageHyponatremia is a frequent complication of subarachnoid hemorrhage (SAH) with a prevalence of 30 to 50% in patients with this condition. This hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders. Also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with SAH. The kinetics and relationship between hyponatremia and these changes remain unknown. The main objective of the study is to determine whether the change in cerebrospinal fluid (CSF) composition, precedes the development of hyponatremia. For this, the investigators propose to study the evolution of the CSF ionogram with the blood ionogram. Furthermore, they will perform additional analyses on the basis of a control group (CSF of patient with normal pressure hydrocephalus) to determine the effect of SAH on ionic changes. The hypothesis of the study is that there is a correlation between the change in CSF blood ionogram and the development of hyponatremia between day 0 and day 14.
Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With...
Cerebrovascular StrokeIntracranial Hemorrhages2 moreThis study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.
The Effect of Time Window for Umbilical Cord Clamping During Cesareans on Offspring Hemoglobin and...
Delayed Cord ClampingHemoglobin1 moreThis is a randomized controlled trial, aiming to evaluate the effects of time window for umbilical cord clamping during cesarean section on the health outcomes of offspring hemoglobin,maternal blood loss,and children's growth and development. It will be conducted in Liuyang city and Huantai county of China, and the targeted sample size is 360 (180 in each site). All the eligible pregnant women will be randomly assigned to one of the four groups (three intervention groups and one control group), and their babies will be followed up to 18 months of age.
Reducing Postpartum Hemorrhage After Vaginal Delivery
Postpartum HemorrhageVaginal DeliveryPostpartum hemorrhage is the primary cause threatening the life safety of pregnant women in the world and China, and also the main cause of hysterectomy for women giving birth. The management of postpartum hemorrhage necessitates a coordinated multidisciplinary approach but limited available data on this issue. This program aims to evaluate the effectiveness and acceptability of the integrated strategies, on postpartum hemorrhage after vaginal delivery and relevant clinical practice, in response to the increasing incidence of postpartum hemorrhage and its long-standing threaten to the life safety of pregnant women. A matched-pair, cluster-randomized controlled trial will be conducted among 50 maternity hospitals with at least 500 vaginal deliveries annually from five provinces in China. Recruited hospitals will be randomly assigned in a 1:1 ratio to either the experimental or comparison arms. All hospitals will receive general interventions, including: recommendation for implementing quality improvement programs to reduce vaginal delivery complications; trainings on obstetric quality management and clinical skills (3 times a year); and monitoring postpartum hemorrhage rate every month. The hospitals in the experimental group will additionally implement integrated improvement strategies which include postpartum hemorrhage risk screening, hierarchical management and preparedness, rescue recording, and case review. The primary outcome is the rate of postpartum hemorrhage, and the secondary outcomes include rate of consequent adverse outcomes, adherence to all known best practices, and staff acceptability to the interventions. These outcomes will be measured and compared between the experimental and control groups. Both intention-to-treat and per-protocol analyses will be performed.