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Coagulation clinical trials

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NCT ID: NCT01921595 Terminated - Coagulation Clinical Trials

Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery

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

The purpose of study is to compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.

NCT ID: NCT01428102 Terminated - Coagulation Clinical Trials

RapidTEG MA Validation

R-TEG MA
Start date: July 2011
Phase: N/A
Study type: Observational

During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). However, should this homeostatic balance be upset, normal hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding (hemorrhage). In instances that include acquired or congenital abnormalities of the hemostatic system it is clinically important to diagnose, monitor and manage the patient to optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain the homeostatic balance. The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets with the protein coagulation cascade from the time of placing the blood in the analyzer until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa, through eventual clot lysis. It displays both qualitatively and quantitatively the two distinct parts of hemostasis - the part that produces the clot and the part that causes the breakdown of the clot. It shows the balance or degree of imbalance in the patient's hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of the patient's hemostasis condition. If the system is not in balance, one can see where the imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as soon as possible in order to start the proper treatment. By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways which initiate and result in clot formation. This RapidTEG™ reagent can deliver results faster than activating with Kaolin alone. This protocol will specifically assess one algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot. This represents platelet function. The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs. MA Kaolin.

NCT ID: NCT01357928 Completed - Coagulation Clinical Trials

Thromboelastography (TEG) Reference Range Study

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

As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.

NCT ID: NCT01121510 Withdrawn - Coagulation Clinical Trials

Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device. patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the QuickClose Design 9. Patients will be monitored until 30 days after the procedure.

NCT ID: NCT00990158 Completed - Bleeding Clinical Trials

Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability?

OVWAC VII
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Warfarin is highly effective for the prevention of both first and recurrent thrombotic events, however even minor excursions outside the reference INR range of 2.0 to 3.0 are associated with bleeding or thrombotic complications. The importance of maintaining the INR within the desired interval has led to the concept of "time in therapeutic range (TTR)" - the total proportion of time that the INR is between 2.0 and 3.0. The investigators propose a multicentre, double blind, randomized trial which will determine if 0.150 mg of oral vitamin K increases time in the therapeutic range for patients receiving warfarin.

NCT ID: NCT00933738 Completed - Coagulation Clinical Trials

Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)

ECLIPSE 03
Start date: December 2009
Phase: N/A
Study type: Observational

This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.

NCT ID: NCT00909298 Terminated - Coagulation Clinical Trials

Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% reduction of thrombin generation markers at 28 days compared to placebo.

NCT ID: NCT00839995 Completed - Coagulation Clinical Trials

Use of ROTEM for Multi-level Spine Surgery

ROTEM
Start date: February 2009
Phase: N/A
Study type: Observational

The purpose of this study is to obtain coagulation profiles of patients undergoing multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will compare the data from ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.

NCT ID: NCT00794755 Completed - Coagulation Clinical Trials

Low Dose Supplementation to Improve Anticoagulation Control With Oral Vitamin K as an Adjuvant to Warfarin Therapy

LOCK
Start date: November 2008
Phase: Phase 3
Study type: Interventional

The main objective of this study is to assess the effectiveness of low dose Vitamin K1 (200 micrograms per day) at improving anticoagulation control in unstable patients on warfarin. This study will also aim to look at effectiveness in the context of genes known to influence warfarin metabolism, variability in the consumption of Vitamin K rich foods, and patient knowledge about warfarin anticoagulation -- factors which have been associated with anticoagulation control and which can influence the effectiveness of this intervention in clinical practice.

NCT ID: NCT00705991 Completed - Coagulation Clinical Trials

Validation of Thrombelastometry (ROTEM®)

Start date: January 2008
Phase: Phase 4
Study type: Observational

Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von: i) Reproduzierbarkeit von ROTEM® ii) Präzision der ROTEM®-Tests, sowie iii) der Zeitspanne, während derer die Ergebnisse in Zitrat-Blut reproduzierbar sind Die durchzuführenden Tests sind FIBTEM, EXTEM, INTEM in ROTEM® um die Funktion der Thrombozyten während der Lagerungszeit zu untersuchen. Nur Zitrat-Blut wird den Patienten abgenommen, die Reklazifikation findet kurz vor der Durchführen der Tests stattfinden, um so nahe wie möglich an der klinischen Praxis zu sein.