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Hemorrhage clinical trials

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NCT ID: NCT00985920 Completed - Clinical trials for Total Knee Arthroplasty

Topical Tranexamic Acid for Total Knee Arthroplasty

Start date: September 2007
Phase: Phase 4
Study type: Interventional

Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed study is to determine the role of topical application of tranexamic acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal drop in hemoglobin concentration following surgery. This proposal describes a randomized, double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include transfusion requirements, hospital stay, joint functionality, quality of life and safety of using topical TA. Topical application of TA is a novel intraoperative approach that has not been used or studied in TKA. However if it is effective, it will directly reduce postoperative intra-articular bleeding without subsequent systemic absorption and thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will lead to less pain and infection rates as well as improved surgical functional outcomes.

NCT ID: NCT00984126 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Start date: October 26, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

NCT ID: NCT00982683 Completed - Hemorrhage Clinical Trials

Association of Lunar Phases With Post-surgical Morbidity

Start date: January 1998
Phase: N/A
Study type: Observational

The potential influence of lunar phases on human life has been widely discussed by the lay press. The purpose of this study was to evaluate a possible relation between the lunar cycle and the hemorrhagic complication rate and surgical outcome. PATIENTS AND METHODS: The investigators tested this hypothesis by evaluating the complication rate for 18760 patients who underwent surgery from January 2001 to December 2008 (103 lunar phases) at the National Institute for Cancer Research in Genoa. The date of definitive surgery was allocated to the lunar phases.

NCT ID: NCT00977925 Completed - Clinical trials for Soft Tissue Bleeding

The Severe Soft Tissue Bleeding Study

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

NCT ID: NCT00974701 Completed - Clinical trials for Upper Gastrointestinal Hemorrhage

A Pilot and Feasibility Study to Evaluate Capsule Endoscopy

MA-79
Start date: August 2009
Phase: N/A
Study type: Interventional

This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO 2 Capsule in: - Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI) tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3) discriminating a variceal versus non-variceal source of UGI bleeding.

NCT ID: NCT00968227 Completed - Clinical trials for Subarachnoid Hemorrhage

Effect of Red Blood Cell Transfusion on Brain Metabolism in Patients With Subarachnoid Hemorrhage

Start date: November 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if giving blood transfusions to anemic patients with subarachnoid hemorrhage will reduce their chances of having a stroke from vasospasm.

NCT ID: NCT00968045 Completed - Clinical trials for Coronary Artery Disease

Fibrinogen and Bleeding After Cardiac Surgery

Fibro-3
Start date: April 2009
Phase: Phase 2
Study type: Interventional

The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.

NCT ID: NCT00966355 Completed - Clinical trials for Variceal Bleeding, Cirrhosis

Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Start date: September 2006
Phase: Phase 4
Study type: Interventional

This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

NCT ID: NCT00964548 Completed - Clinical trials for Cerebral Vasospasm After Subarachnoid Hemorrhage

Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP. Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.

NCT ID: NCT00964496 Completed - Clinical trials for Obscure Gastrointestinal Bleeding

Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation

Start date: November 2004
Phase: Phase 2
Study type: Interventional

Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge. Methods: The investigators performed a randomized, parallel controlled study of thalidomide as a therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients with at least six episodes of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed a four-month regimen of either 25 mg of thalidomide or 100 mg of iron orally four times daily, and monitored for at least one year. The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months and the cessation of bleeding. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes included the participants dependent on blood transfusions and changes from baseline in transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months. Statistical significance was defined at P < 0.05.