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Blood Coagulation Disorders clinical trials

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NCT ID: NCT03674684 Completed - Coagulopathy Clinical Trials

ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation

Start date: September 14, 2017
Phase:
Study type: Observational

Modern crystalloid and colloid solutions are balanced solutions which are increasingly used in perioperative period. However, studies investigating their negative effect on whole blood coagulation are missing. The aim of our study was to assess the effect of modern balanced crystalloid and colloid solutions on whole blood coagulation in vivo using rotational thromboelastometry.

NCT ID: NCT03666650 Completed - Clinical trials for Blood Coagulation Disorder

NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers

EdoRot
Start date: November 26, 2018
Phase: Phase 4
Study type: Interventional

Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis

NCT ID: NCT03647644 Completed - Bleeding Clinical Trials

Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Start date: January 31, 2018
Phase:
Study type: Observational [Patient Registry]

The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.

NCT ID: NCT03634215 Completed - Clinical trials for Coagulation Disorder

Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma

Start date: September 1, 2018
Phase:
Study type: Observational

Coagulation factor XIII (FXIII), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. It also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. It has been found that similar to plasma fibrinogen level, FXIII activity can be reduced in the early phase of severe trauma. Therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. However, unlike plasma fibrinogen level evaluation, measurement of the FXIII activity is not routinely available. Therefore, targeted substitution of FXIII is practically impossible. The plasma fibrinogen level is routinely measured in severe trauma patients. Based on pathophysiologic assumptions and a limited number of published data we hypothesize that the FXIII activity correlates with fibrinogen level. In such case, indirect FXIII activity prediction by fibrinogen level measurement would be a convenient approach to enable FXIII targeted substitution. Therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased FXIII activity.

NCT ID: NCT03616808 Completed - Bleeding Clinical Trials

Thromboelastometry-identified Haemostatic Changes in Isolated Traumatic Brain Injury

THROMBIN
Start date: August 21, 2018
Phase: N/A
Study type: Interventional

A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury. Patients undergoing craniotomy to treat traumatic brain injury will be enrolled. All patients will undergo standard perioperative coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count), whereas ROTEM-guided group will additionally be tested with ROTEM. "Cases" will be managed according to a ROTEM-based algorithm, and "Controls" will be treated as usual (based on clinical judging). Comparative analysis of acquired demographic, clinical and laboratory data will be performed. The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.

NCT ID: NCT03598907 Terminated - Clinical trials for Lung Transplantation

Point-of-care Management of Coagulopathy in Lung Transplantation

Start date: January 1, 2018
Phase:
Study type: Observational

Pulmonary transplantation is a very demanding surgical procedure, often accompanied by coagulopathy and severe perioperative bleeding. The most common complication that develops within the first 72 hours after surgery is primary graft dysfunction (PGD), up to 30% in the most severe form. The etiology of PGD is multifactorial. One of the causes may be the amount of perioperative blood loss. Intravascular volume is normally maintained by the administration of crystalloid and colloid solutions and fresh frozen plasma, which is also used to treat coagulopathy, however it is administered at the discretion of the anaesthetist and his experience, practically meaning ,,blindly". In the field of the allogeneous ischemic organ, these substitution solutions essentially become another allogeneous material and can cause undesired immunomodulation and contribute to the development of PGD. In our prospective randomized trial (120 patients), two patient groups will be investigated. In the first group, the coagulopathy and perioperative blood loss will be treated by the current standard approach, by ,,blind" administration of fresh frozen plasma, crystalloids and colloids. In the second group, the cause of coagulopathy will be diagnosed and treated according to the point-of-care (POC) results of ROTEM, PFA 200 and Multiplate. A colloidal solution of 5% albumin will be used to replace the circulating volume and maintain the oncotic pressure. Investigators assume that the POC management of coagulopathy and bleeding in the second group will lead to a reduction in perioperative bleeding, to reduced administration of infusion solutions, and thus to a reduction of the incidence of PGD.

NCT ID: NCT03592303 Not yet recruiting - Clinical trials for Post Partum Hemorrhage

Bedside Assessment of Coagulation in Post-partum Hemorrhage by Thromboelastography (TEG ®6S)

HPPTEG6S
Start date: August 2018
Phase:
Study type: Observational

Postpartum hemorrhage (PPH) is one of the leading causes of maternal deaths. Its prognosis is directly influenced by the early diagnosis and treatment of the associated coagulopathy. In this context, fibrinogen concentration is the best predictor of a severe PPH. The medical interest of thromboelastography/elastometry to early detect and guide the rapid correction of coagulopathy in PPH is regularly discussed. The principal aim of this study is to evaluate the performance of a new hemostasis point of care device (thromboelastography - TEG ®6S) for the diagnosis of coagulopathy during PPH. A secondary aim will be to determine the normal values of TEG6S at the end of a normal pregnancy.

NCT ID: NCT03572309 Recruiting - Trauma Clinical Trials

Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

TICAF
Start date: July 23, 2018
Phase:
Study type: Observational

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

NCT ID: NCT03570281 Recruiting - Clinical trials for Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)

Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)

ENCHASE
Start date: June 15, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.

NCT ID: NCT03566303 Terminated - Stroke Clinical Trials

Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis

RIWA
Start date: July 10, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Mechanical heart valves (MHV) demand lifelong anticoagulation with vitamin K antagonists (VKA) due to the high thrombogenicity of the prosthesis. Rivaroxaban has previously been tested in experimental and animal models with encouraging results. The investigators recently sent for publication an experiment with 7 patients who used rivaroxaban in metallic prosthesis with encouraging results. In this way it was decided to do a randomized non-inferiority clinical trial comparing rivaroxaban with warfarin in patients with metallic prosthesis.