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Hemorrhage clinical trials

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NCT ID: NCT02117128 Completed - Blood Loss Clinical Trials

The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

Start date: April 2014
Phase: Phase 4
Study type: Interventional

We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.

NCT ID: NCT02108327 Completed - Blood Loss Clinical Trials

Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA

TKA
Start date: April 2014
Phase: N/A
Study type: Interventional

Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).

NCT ID: NCT02106000 Completed - Haemorrhage Clinical Trials

A Non-investigational Product (IP) Study to Investigate Lung Function in Women in the Third Stage of Labour

Start date: June 24, 2014
Phase: N/A
Study type: Observational

The purpose of this study is to record and compare the inhalation profiles of non pregnant women and those who are in the third stage of labour. The inhalation profiles will be recorded from consenting women as they inhale with maximal effort through an inhalation profile recorder [Glaxosmithkline (GSK), Ware]. The recorder will simulate resistance to airflow and will be representative of a dry powder inhaler of moderate resistivity. The inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be compared between the two female cohorts. Inhalation profiles recorded in this way may subsequently be used to study the in-vitro performance of investigational materials across inhalation parameters representative of the target patient population. An appropriate number of subjects will be consented so that approximately 40 subjects (20 non-pregnant females and 20 stage three labour subjects) complete assessments. The inhalation profiles will be recorded on the same day of screening or at another time within a span of 50 days

NCT ID: NCT02104947 Completed - Hemorrhage Clinical Trials

Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Start date: May 6, 2014
Phase: Phase 3
Study type: Interventional

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

NCT ID: NCT02103101 Completed - Hemorrhage Clinical Trials

Influence of ABCB1 Polymorphisms on Plasma Concentrations of New Oral Anticoagulants in Case of Serious Adverse Events

Pgp NACO
Start date: November 13, 2014
Phase: N/A
Study type: Interventional

Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now available on the market. These NOACs, like all anticoagulant drugs, continue to be associated with an increased risk of bleeding. In addition, the lack of antidote and the absence of valid data regarding biological monitoring can pose problems in case of overdose or when emergency surgery is required. Studies investigating the pharmacokinetic properties of rivaroxaban and dabigatran, two NOACs now approved for the market, have shown high variability between individuals, with coefficients of variation of up to 60% for some pharmacokinetic parameters in patients treated after orthopaedic surgery. The relation between plasma concentrations of NOAC and bleeding risk has been clearly established in clinical trials. Dabigtran, rivaroxaban and apixaban are known substrates of P-glycoprotein (Pgp). Pgp activity can be affected by pharmacological inducing or inhibiting agents. This can lead to a significant change in the pharmacokinetics of NOACs, with a decrease or increase (respectively) in the level of intestinal absorption, leading to respectively reduced or increased plasma concentrations of the drug. Furthermore, there exist genetic mutations of Pgp, presenting in particular a lower level of activity than the non-mutated protein. We hypothesized that the polymorphisms (mutations) of the ABCB1 gene that codes for Pgp could influence plasma concentrations of dabigatran, rivaroxaban and apixaban, and consequently, impact on the concentration of NOACs and as a corollary, on the bleeding and thromboembolic risk of patients treated with these molecules. The main objective of this study is to study the relation between polymorphisms of the ABCB1 gene that codes for Pgp and plasma concentrations of NOACs in patients treated for a hemorrhagic or thromboembolic complication occurring under NOAC therapy. Secondary objectives are to evaluate the distribution of ABCB1 polymorphisms among the various hemorrhagic risk factors, and to compare the frequency of the polymorphism in patients from the study population vs the general population.

NCT ID: NCT02101567 Completed - Anemia Clinical Trials

Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section

Start date: May 2014
Phase: Phase 4
Study type: Interventional

The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

NCT ID: NCT02099435 Completed - Colonic Polyp Clinical Trials

Study of Hemospray for Lower Gastrointestinal Hemorrhage

Start date: January 2015
Phase: N/A
Study type: Observational

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

NCT ID: NCT02094885 Completed - Hemorrhage Clinical Trials

The Bioseal Vascular Study

Start date: February 1, 2014
Phase: Phase 4
Study type: Interventional

To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.

NCT ID: NCT02088385 Completed - Clinical trials for Bleeding Peptic Ulcers

Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study

Start date: November 2013
Phase: N/A
Study type: Interventional

Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.

NCT ID: NCT02086500 Completed - Clinical trials for Traumatic Hemorrhage

Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)

STAAMP
Start date: July 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given during emergency medical transport to a level 1 trauma center in patients at risk of hemorrhage is associated with lower 30 day mortality.