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Gastrointestinal Hemorrhage clinical trials

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NCT ID: NCT00839358 Completed - Sepsis Clinical Trials

Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation

MACHT
Start date: August 2008
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.

NCT ID: NCT00838864 Completed - Clinical trials for Gastrointestinal Hemorrhage

Comparison of 3 Days and 7 Days Intravenous Ceftriaxone Prophylaxis for Variceal Bleeding

Start date: March 2009
Phase: Phase 4
Study type: Interventional

Prophylactic antibiotics have been routinely recommended for cirrhotic patients with upper gastrointestinal bleeding recently. However, the regimen and duration of its use remain an inconclusive issue. Quinolones and 3rd generation cephalosporins have been more often used for prophyalxis recently. The duration for antibiotic usage were variable in the literatures, ranged from 4-10 days. The latest guideline from AASLD in 2007 was 7 days. In the survey of infections in cirrhotic patients with UGI bleeding performed by Bernard et al, most infections occurred in the first 5 days and half within the first 48 hours. Therefore, considering the cost-effectiveness and drug resistance issues, the necessity for such prophylaxis for 7 days may need to be re-evaluated. The purpose of our study is to investigate the antibiotic prophylaxis duration for cirrhotic patients with acute gastro-esophageal variceal bleeding. We will enroll those patients suffering from variceal bleeding documented by endoscopic examination and without apparent evidence of infection. Those who have received antibiotics within 2 weeks, are less than 18 years old, get pregnant, have malignancy other than HCC, have allergy to ceftrioxone are excluded. After receiving well explanation and giving consent, these patients are randomly allocated to 2 groups and receive prophylactic antibiotic just after endoscopic examination; Group I: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 3 days, Group II: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 7 days. They will receive appropriate endoscopic treatment for gastro-esophgeal varices and glypressin 1mg q6h for 3 days. They will start to feed on the 2nd day if not contraindicated. The 2nd endoscopic treatment for varices will be performed 2 weeks later. We record the demographic data, vital signs, transfusion amount; check hemogram, U/A, CXR, ascites routine (with apparent ascites), classification of variceal size and Child-Pugh classification. We monitor the events of rebleeding & infection, transfusion amount and hospitalization days We use rebleeding rate within 14 days as the primary end point. It is defined as the following events after initial stabilization of vital signs for 24 hours; (1): recurrence of hematemesis or bloody stool (2); need of transfusion more than 2 unit of blood and systolic pressure < 100 mmHg or pulse rate > 100/mn. We use infection rate during admission and mortality rate within 28 days as secondary end points.

NCT ID: NCT00797641 Completed - Clinical trials for Gastrointestinal Hemorrhage

European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)

ENERGIB
Start date: January 2009
Phase: N/A
Study type: Observational

The aim of this study is to assess the current management strategies in a pan-European "real-life" setting to uncover the unmet need in this area: non-variceal gastrointestinal bleedings.

NCT ID: NCT00694954 Completed - Clinical trials for Iron Deficiency Anemia

Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

Start date: February 2007
Phase: N/A
Study type: Interventional

The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI) bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.

NCT ID: NCT00690027 Completed - Clinical trials for Survival and Control of Bleeding

San Diego Bleeding Esophageal Varices Study

Start date: April 1988
Phase: N/A
Study type: Interventional

In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of: - Emergency portacaval shunt, and - Emergency and long-term endoscopic sclerotherapy.

NCT ID: NCT00689754 Completed - Liver Cirrhosis Clinical Trials

Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed

NG
Start date: January 2008
Phase: N/A
Study type: Interventional

Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to obtain important clinical data and make therapeutic decisions. But routine use of NGA remains controversial with studies reporting its usefulness and its redundant clinical information. Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to allow for risk stratification and to perform endoscopic treatments. The results of the NGA may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that presence of NGA can identify lesions that require endoscopic treatment and provides important clinical information to guide the treating physician. In addition, we hypothesized that the results of the NGA influence the clinical decision of the treating physician regarding the prediction of the need for endoscopic therapy. This observational randomized cross-sectional study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no NGA recording its results. All patients will receive an EGD and its results will also be recorded. Subsequently, we will evaluate if the NGA is important in identifying endoscopically significant lesions. The information gained will help guide clinicians evaluating patient with UGIH.

NCT ID: NCT00570973 Completed - Cirrhosis Clinical Trials

Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy

ENDOvsTIPS
Start date: November 2004
Phase: Phase 4
Study type: Interventional

Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented non response to medical therapy with non selective beta blockers +/- mononitrates or variceal rebleeding during adequate medical therapy will be randomized to undergo either multi-session endoscopic multi-band ligation and continuation of medication or TIPS placement. Best treatment for this group of cirrhotic patients is not known so far.

NCT ID: NCT00450164 Completed - Cirrhosis Clinical Trials

Secondary Prophylaxis After Variceal Bleeding in Non-Responders

KT-2000
Start date: November 2000
Phase: Phase 4
Study type: Interventional

Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.

NCT ID: NCT00402259 Completed - Clinical trials for Gastrointestinal Hemorrhage

Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding

Start date: August 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding

NCT ID: NCT00389935 Completed - Clinical trials for Hereditary Hemorrhagic Telangiectasia

Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding

TAG
Start date: October 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.