Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter...
Aortic Valve DiseaseAortic Valve Stenosis5 moreTranscatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen. Hypothesis: Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days
Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
Gastrointestinal Hemorrhage (Clinically ImportantUpper)Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, today, compared to decades ago, critically ill patients rarely develop gastrointestinal bleeding. This decrease is likely due to modern medicine, better resuscitation and earlier feeding. There may also be harms associated with pantoprazole and other drugs that reduce acid levels in the stomach including lung infections (pneumonia) and bowel infections (clostridium difficile). Studies in this area are old and of modest quality. Therefore, it is difficult to know whether pantoprazole does decrease stomach bleeding these days, or whether the possible harms of lung and bowel infections are actually more common and more serious problems. The goal of this international study is to determine if, in critically ill patients using breathing machines, the use of pantoprazole is effective in preventing bleeding from stomach ulcers or whether it causes more problems such as lung infection (pneumonia) and bowel infection (Clostridium difficile), or whether pantoprazole has no effect at all. Whether the harms are worth the benefits, and whether the benefits are worth the costs, will be determined by an economic analysis to inform patients, families, clinicians, and healthcare systems globally.
Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Myomectomy; Surgical Blood LossPurpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.
Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
Von Willebrand DiseasesPostpartum HemorrhageThis is a single-center randomized phase III clinical trial, the VWD-Woman Trial, in which 20 pregnant subjects with von Willebrand disease (VWD), defined as VWF ristocetin co-factor activity (VWF:RCo) <0.50 IU/ml (historic) and previous history of bleeding are enrolled. Subjects will include women with VWD age 18 years and older, excluding those who have a bleeding disorder other than VWD. Once enrolled, subjects who meet all of the inclusion and none of the exclusion criteria will be randomized to recombinant Von Willebrand factor (rVWF, Vonvendi ®) with Tranexamic Acid (TA, Cyclokapron®); or recombinant Von Willebrand factor (rVWF, Vonvendi®) alone to prevent postpartum hemorrhage after vaginal or caesarean delivery. The primary endpoint is quantitative blood loss (QBL) by a labor suite nurse at delivery. Secondary endpoints include safety assessment for postpartum lochial blood loss by Pictorial Blood Assessment Chart (PBAC), transfusion, blood products, thromboembolic events, and hysterectomy within 21 days; and mechanism of PPH reduction by VWF assays (VWF:RCo, VWF:Ag, VIII:C), fibrinogen, and d-dimer. Blood draws are at 5 time points, including at 36 weeks' gestation (screening), on admission for childbirth, and at 1 day, 2 days, and 21 days after delivery. The VWD-Woman Trial is considered greater than minimal risk as study drugs are given at delivery and special coagulation studies are obtained.
Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage...
Postpartum HemorrhageImmediateIntrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little is known about how long the IUBT should be used once placed. Though it is common to use IUBT for 12-24 hours, the balloon may be equally effective when used for shorter durations of time, which could have beneficial effects for patients and hospitals. The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in controlling postpartum hemorrhage. The specific aims of the proposed study are to determine: 1) whether quantitative blood loss significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3) whether shorter duration of IUBT placement has beneficial effects including shortened postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain prior to maternal discharge from hospital. We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is no clinically significant difference in postpartum blood loss when the balloon is removed 6 hours after placement compared to 18 hours after placement.
Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection
Gastro Intestinal BleedingPolypsSafety and effectiveness of a new hemostatic system to prevent delayed bleeding after endoscopic resection in a selected high-risk population (NEXPOWDER- ENDOHS). Indication: Patients with indication of endoscopy resection by endoscopic mucal resection (EMR) or endoscopic submucosal dissection (ESD) with high risk of delayed bleeding (≥5%). Hypotheses: The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.
Prophylactic Methylergonovine for Twin Cesarean
Twin; Complicating PregnancyPostpartum HemorrhageObstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery. The purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.
Colonoscopic Sucralfate Spray in Prevention of Delayed Polypectomy Bleeding
BleedingBackground: Colonoscopy can detect colon polyps and perform excision to the polyps to prevent colon cancer. However, polypectomy bleeding is one of the complications to be noticed, which has an occurrence rate of about 0.4%. Polypectomy bleeding is divided into two types, immediate and delayed bleeding. While immediate polypectomy bleeding can be treated with endoscopic hemostasis during the exam session, delayed polypectomy bleeding occurs a few hours or days after the colonoscopy exam. Patients who encountered delayed polypectomy bleeding usually presented to the hospital for hematochezia, symptoms of anemia, and even hemodynamic instability and end-organ damage. Cold snare polypectomy and prophylactic clipping can reduce the bleeding risk. However, delayed polypectomy bleeding still occurs in high-risk patients, e.g., larger polyps ≥ 1cm. Sucralfate is used for peptic ulcer treatment. It can become a protective layer on the wound to prevent environmental injury. Sucralfate can be used to treat colon ulcers, colitis, and radiation colitis. Whether sucralfate can prevent polypectomy wounds from delayed bleeding is unknown. Aim: This study aimed to investigate whether precise sucralfate administration on polypectomy wounds can prevent the wound from delayed bleeding. Method: This is a randomized clinical trial. The study will recruit 160 patients. After randomization, 80 patients will be classified into the intervention group and 80 into the control group. The participants will receive an endoscopic survey as routine, and we will enroll all patients with polyp size ≥ 0.5 cm after polyp excision. Exclusion criteria include patients with an allergy to sucralfate. If immediate polypectomy bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine, heater probe coagulation, and/or hemoclipping. If there is no immediate bleeding, we will apply prophylactic clipping in high-risk patients with polyp size ≥ 1cm. After then, we will spray 3g of sucralfate powder through colonoscopy precisely on the polypectomy wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 28 days after the colonoscopy.
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage...
Transcranial Ultrasound With Sonolucent CranioplastyTUSCPostoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires significant physical and financial costs. Studies have demonstrated varying degrees of efficacy when using transcranial ultrasound to measure ICH volume. Recently, synthetic implants for cranioplasty have been shown to be safe and sonolucent. This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH patients.
Kaolin-based Hemostatic Gauze in Total Knee Arthroplasty
Total Blood LossArthropathy of Knee JointThis study is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and QCG in a primary TKA procedure.