Active clinical trials for "Hemorrhage"

ABSTRACT: Delayed ischemic deficits (DID) and strokes caused by low cerebral blood flow (CBF) are major sources of poor outcome following aneurysmal subarachnoid hemorrhage (SAH). DID are often accompanied by vasospasm and abnormalities in cerebrovascular autoregulation, an important reflex involved in the defense against low CBF. Assessment of vasospasm and impaired autoregulation can be conveniently measured non-invasively by use of transcranial Doppler (TCD) and the transient hyperaemic response test (THRT). Vasospasm and abnormalities in the THRT can predict those patients who are at risk of developing DID. In this study, the investigators wish to explore the neuroprotective and angiogenic effects of systemic erythropoietin (EPO) therapy on vasospasm and autoregulation following SAH, and examine whether any improvements translate into reduced incidences of DID and poor outcome. Eighty patients with SAH will be recruited over one year to receive three doses in the first week of either intravenous epoetin beta 30000 IU or placebo (0.9% saline) 50 ml/30 min as part of a randomized, double-blind, placebo-controlled trial. The investigators propose daily TCD assessment for detecting vasospasm and abnormal autoregulation. Outcome measures will examine the influence of EPO therapy on the incidence, severity, and duration of vasospasm, abnormal autoregulation, and DID. PURPOSE: This study is a randomized, double-blind, placebo-controlled clinical trial investigating the potentially beneficial effects of systemic recombinant human erythropoietin therapy (Epoetin beta, NeoRecormon®, Roche, 30000IU/50 ml/30 min, three times in the first week) on cerebral autoregulation and incidence of delayed ischemic deficits (DID) following aneurysmal subarachnoid haemorrhage (SAH). HYPOTHESIS Systemic recombinant human erythropoietin therapy can be used safely following SAH to ameliorate vasospasm, improve cerebral autoregulation, reduce DID, and facilitate neurological recovery.

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA). The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.

The main objective of this study is to evaluate the safety, tolerability and pharmacokinetics of Cerebril™ in Cerebral Amyloid Angiopathy (CAA) patients who have had lobar cerebral hemorrhage.

Oxytocin causes myometrial contraction via the oxytocin receptor (OTR). Desensitization of the OTR after exposure to oxytocin has been demonstrated in previous studies. The resultant need for a higher oxytocin dose to cause adequate uterine contraction in vivo has also been demonstrated in laboring women having received oxytocin for labor augmentation. Achieving rapid uterine relaxation can be invaluable for maternal and fetal wellbeing in some acute obstetric emergency settings. Nitroglycerin has become a commonly used agent for achieving rapid uterine relaxation amongst obstetric anesthesiologists. Previous studies have concluded that oxytocin can be used to re-establish uterine tone following nitroglycerin mediated relaxation. However, no studies to date have looked at the effects of nitroglycerin mediated relaxation of uterine muscle that has undergone oxytocin receptor desensitization. Nor has the response to oxytocin re-exposure and return of contractility in desensitized myometrium (following nitroglycerin) been examined. The investigators hypothesize that nitroglycerin will reduce and inhibit uterine contractions in both oxytocin pre-treated myometrium, as well as untreated myometrium in a dose dependent fashion, but that myometrium that has undergone OTR desensitization will require less nitroglycerin for contractions to abate. The investigators also expect that the dose of oxytocin required to re-establish equivalent contractions will be higher in the myometrial samples which have undergone nitroglycerin mediated relaxation.

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage. Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.

EMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a "safety cushion" as such between the area to be removed and healthy mucosal tissue. Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S. A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml). Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate. This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.

Knee arthroplasty is performed with restriction of blood flow by use of the pressure tourniquet. Ischemia of skeletal musculature is accompanied by the formation of reactive oxygen species and release of vasoactive factors. Inhaled anesthetics were described as possible protective factors, termed "ischemic preconditioning". The objective of this investigation is to observe the effects of preconditioning with inhaled anesthetic on bleeding in the postoperative period of knee arthroplasty surgery. The study will be prospective and randomized. Patients will be allocated by means of a randomized table in two groups: Group Preconditioning (GP) - subarachnoid and general anesthesia with preconditioning with 1 minimal alveolar concentration (MAC) for 15 minutes before the installation of the ischemia by tourniquet; Group control (GC) - subarachnoid and general anesthesia with sevoflurane without preconditioning. Will be evaluated: hemoglobin and hematocrit, platelet count and coagulogram, electrolytes and creatinine, lactate and glycemia. Volume of drainage will be evaluated until drainage is withdrawn and need for transfusion measuring the number of bags of blood concentrate and volume transfused. Pain assessment will be done by means of visual analog scale. Morbidity will be recorded up to the 30th postoperative day by chart analysis. Patients will be allocated to the study groups by random number table. Data will be presented descriptively, frequently, mean and standard deviation, or medians and distribution in 25-75% percentiles. The comparison between continuous measurements will be made by means of repeated measures intra-group analysis of variance (ANOVA) and Student's t-test for evaluation between groups. The need for transfusion will be compared by Fisher's exact test. Pain intensity will be compared by Wilcoxon test for non-parametric data. A commercially available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P <0.05 will be considered statistically significant.