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Hemorrhage clinical trials

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NCT ID: NCT01510574 Completed - Clinical trials for Postpartum Hemorrhage

A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)

Start date: May 2012
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally. The investigators envisage that the use of self administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot). The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.

NCT ID: NCT01508429 Completed - Clinical trials for Postpartum Hemorrhage (PPH)

Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

Start date: July 2012
Phase: N/A
Study type: Interventional

Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use. A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta. Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.

NCT ID: NCT01506986 Completed - Clinical trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Helicobacter Eradication Aspirin Trial

HEAT
Start date: March 2012
Phase: Phase 4
Study type: Interventional

HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting centres across the UK. This trial is funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme. Aspirin use is widespread and increasing in elderly patients. The main hazard is gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly in H. pylori positive people. Patients will be identified by their GPs, then asked to attend an appointment with a Research Nurse to consent to the trial and take a H. pylori breath test. Those with a positive result will be randomised to receive a one week course of either eradication treatment or placebo. No follow-up visits are required, but instead information will be extracted from the patients' electronic medical record using the MiQuest search tool. The trial will continue until 87 adjudicated events (hospitalisation because of definite or probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient years of follow-up, if trial assumptions are correct.

NCT ID: NCT01500135 Completed - Bleeding Clinical Trials

Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment in Vascular Surgery

VASUS
Start date: March 2012
Phase: Phase 3
Study type: Interventional

Present trial is one of two trials (the other being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support a general hemostasis indication across several surgical procedures and organ systems in the USA. The patient will come for a screening and baseline visit, the day of surgery and follow up visits after 1 months, 3 months and 6 months. The enrollment period is planned for 16 months and 6 months of follow up.

NCT ID: NCT01498705 Withdrawn - Clinical trials for Intracerebral Hemorrhage

The Natural History of Procalcitonin in Hemorrhagic Stroke

Start date: December 2011
Phase: N/A
Study type: Observational

Approximately 12% of strokes in the United States are hemorrhagic.1 Hemorrhagic stroke can lead to multiple complications including fever that is not infectious. Identifying the cause of fever can help physicians choose the best care for the patient to try and prevent further damage to the already injured brain. Bacterial infection is one possible cause of fever in the stroke patient; however an incorrect diagnosis of infection can lead to unnecessary antibiotic use. Better screening tools for infection are being developed to help fight the problem of antibiotic resistance and unnecessary antibiotic use. Unnecessary use of antibiotics in patients increases the risk of adverse events and overall healthcare costs. Procalcitonin (PCT) is one such screening tool which has been used previously to help tell apart bacterial and nonbacterial causes of infection in other disease states; however, PCT has not been studied in hemorrhagic stroke patients. The purpose of this study is to understand the progress of PCT in hemorrhagic stroke patients in order to see whether PCT can be a useful marker for infection in these patients.

NCT ID: NCT01497756 Completed - Clinical trials for Postpartum Hemorrhage

Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

Start date: August 2011
Phase: N/A
Study type: Interventional

A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.

NCT ID: NCT01493791 Withdrawn - Clinical trials for Urogenital Abnormalities

CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women

Start date: November 8, 2011
Phase: Early Phase 1
Study type: Interventional

Background: - CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases, menstrual periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual bleeding in women with fibroids, it may be able to treat abnormal periods in women without fibroids. Objectives: - To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women. Eligibility: - Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. An ultrasound with fluid of the uterus will test for fibroids. Uterine cells will be collected for biopsy. - For the next three menstrual cycles, participants will take either CDB-2914 or a placebo. Treatment will be studied with blood tests and symptom diaries. - At the end of the treatment, participants have three options. They can have surgery at the Clinical Center or have another 3 months of CDB-2914. The third option is to stop treatment at the Clinical Center. - Surgery will be either uterine ablation or hysterectomy. Only women older than age 33 may have a hysterectomy. Blood and urine samples will be collected after surgery. - Both surgery and further treatment participants will have followup exams. - All participants will have a final followup exam 1 year after stopping treatment....

NCT ID: NCT01487837 Completed - Hemorrhage Clinical Trials

Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF < 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.

NCT ID: NCT01487278 Withdrawn - Clinical trials for Postpartum Hemorrhage

Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Start date: n/a
Phase: N/A
Study type: Interventional

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

NCT ID: NCT01485562 Completed - Clinical trials for Postpartum Haemorrhage

Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births

Start date: May 2012
Phase: N/A
Study type: Interventional

A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.