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Coagulopathy clinical trials

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NCT ID: NCT06304714 Not yet recruiting - Hemorrhage Clinical Trials

Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana

WBOTHROPS
Start date: April 1, 2024
Phase:
Study type: Observational

In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage. Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated. The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes. The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena. This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.

NCT ID: NCT06230640 Not yet recruiting - Cardiac Surgery Clinical Trials

Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy

PREDIPOC
Start date: February 2024
Phase:
Study type: Observational

This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global hemostasis®), in cardiac surgery with high risk of bleeding.

NCT ID: NCT04582188 Not yet recruiting - Sepsis Clinical Trials

The Early Coagulopathy for the Prognosis in Sepsis

Start date: November 5, 2020
Phase:
Study type: Observational [Patient Registry]

In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality.

NCT ID: NCT04515420 Not yet recruiting - Clinical trials for Brain Injuries, Traumatic

The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury

Start date: September 1, 2020
Phase:
Study type: Observational

Aim of the study The investigators aim to establish: - Whether noradrenaline (NA) infusion has a significant effect on coagulation and fibrinolysis in patients with severe traumatic brain injury (TBI). - Whether disruption of haemostasis can be recorded with a computerized tomography (CT) scan. - Whether there is a significant difference between the values of haemostasis parameters in the internal jugular vein and the radialis artery. The hypotheses 1. In the early stage of treatment (1-3 hours), an increased formation of thrombin occurs in patients with severe isolated TBI that are treated with NA; consequently, platelet use increases in comparison with patients who don't need NA, as do coagulation factors and hyperfibrinolysis. 2. The concentration of NA correlates with thrombin formation and the correlation is stronger in higher doses of NA. 3. Thrombin formation will decrease more slowly in the group that will receive NA therapy in comparison to the group that will not receive NA therapy.

NCT ID: NCT04115722 Not yet recruiting - Coagulopathy Clinical Trials

Coagulation Parameters in IBD Patients

Start date: November 2019
Phase:
Study type: Observational

1. to assess the incidence of coagulation disorders in IBD patients in comparison with another normal controlled group 2. risk factors that contribute to development of thrombosis in IBD patients 3. to determine the effectiveness of prophlactive anticoagulant measures 4. to determine the association between disease activity and coagulation parameters

NCT ID: NCT03981484 Not yet recruiting - Hemorrhage Clinical Trials

REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy

REPLaCE
Start date: January 2020
Phase: Phase 2
Study type: Interventional

Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.

NCT ID: NCT03444077 Not yet recruiting - Trauma Clinical Trials

Impact of a Prehospital Identification of Trauma Patients in Need for Damage Control Resuscitation.

Start date: July 2018
Phase: N/A
Study type: Interventional

Early identification of trauma patients in need for Damage Control Resuscitation (DCR) has potential to be beneficial for general emergency units that are not expected to be ready for this rare situation 24 hours per day, 7 days per week. It could also be useful for high performing trauma centers to identify such patients earlier and be able to provide earlier adequate treatment. By contrast, initiation of DCR in patients who do not require this aggressive therapy may negatively affect their survival. An early identification of patients who do not require DCR would probably be beneficial (impact on cost-effectiveness and on patients' survival). The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated. There has never been any evaluation of the impact of a prehospital discrimination of trauma patients with or without the need for DCR. The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for DCR. Secondary objectives include evaluation of the feasibility of such discrimination and its impact on cost-effectiveness. We hypothesize that the information will lead to improved quality of care with reduced mortality and morbidity.

NCT ID: NCT02987712 Not yet recruiting - Liver Cirrhosis Clinical Trials

Management of Coagulopathy in Cirrhotic Patients Undergoing Invasive Procedures

Start date: December 2016
Phase: N/A
Study type: Interventional

Recently it has been acknowledged that cirrhotic patients present with "rebalanced hemostasis" that results from decreased levels of both pro-coagulant and anti-coagulant factors, that is not well reflected by conventional coagulation tests (CCTs). Thromboelastography (TEG) might be a more accurate tool in these patients. Numerous guidelines on the management of the cirrhotic patient undergoing invasive procedures have been published but most of them are not evidence based. Current literature, although conflicting, is leaning towards a restrictive approach to prophylactic correction of coagulopathy when performing invasive procedures in cirrhotic patients. The investigators suspect that common practice is more liberal . Considering the well-known adverse effects of blood product administration, the aim of the study is to re-evaluate the clinical management of cirrhotic patients undergoing invasive procedures. Study objectives: asserting whether the use of blood products prior to invasive procedures in cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in place of CCTs, evaluating the rate of complications due to blood product use, and checking how well CCT results correlate with TEG results in these patients. This will be a prospective pre/post TEG protocol implementation study which will include two prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior to minor invasive procedures will be based on CCTs and physicians' clinical judgement. Survey 2: management will be based on a new TEG protocol. The investigators will include cirrhotic patients with coagulopathy who are candidates for an invasive procedure. Subject will be provided with sufficient time to reach a rational, informed decision regarding participation in the study. Data will be collected from the computer based medical record systems, the patient file and directly from the caring physician and will include a thorough medical history and conventional blood tests, including a TEG test. All subjects will be managed according to standard of care. Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused in preparation for the invasive procedures. Secondary endpoints: bleeding complications, transfusion related side effects, 90 day survival and other complications. This will be a prospective (pre/post) study. The calculated sample size needed is 120 subjects, 60 in each group.