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Shock, Hemorrhagic clinical trials

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NCT ID: NCT04814810 Terminated - Hemorrhage Clinical Trials

A 48 Subject Study Using Non-invasive Multi-Technology Measurements for Early Detection of Ongoing Hemorrhage

Start date: February 1, 2021
Phase:
Study type: Observational

Early detection of ongoing hemorrhage (OH) before onset of hemorrhagic shock is a universally acknowledged great unmet need, and particularly important after traumatic injury. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH would save countless lives. This is a single site study, enrolling 48 patients undergoing liver resection in a "no significant risk" prospective clinical trial to: 1) further identify a minimal subset of noninvasive measurement technologies necessary for the desired diagnostic performance, 2) validate the performance of our Phase I algorithm, and 3) re-train the algorithm to a Phase II human iteration. The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.

NCT ID: NCT04684719 Recruiting - Hemorrhagic Shock Clinical Trials

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial

TOWAR
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.

NCT ID: NCT04667468 Completed - Trauma Clinical Trials

Cold Stored Platelet in Hemorrhagic Shock

CriSP-HS
Start date: June 21, 2022
Phase: Phase 2
Study type: Interventional

The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize 5 level-1 trauma centers from within the LITES network and will enroll approximately 200 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 24 hour mortality.

NCT ID: NCT04663087 Terminated - Hemorrhage Clinical Trials

Feasibility of Evaluating XSTAT Use in the Prehospital Setting

PhoXSTAT
Start date: October 29, 2022
Phase: N/A
Study type: Interventional

This study evaluates the prehospital use of the XSTAT device to control bleeding in junctional wounds. Participants will be randomized to the use of XSTAT versus standard care.

NCT ID: NCT04610814 Recruiting - Hemorrhagic Shock Clinical Trials

Blood Transfusion by Boston MedFlight Registry

Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

The primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by Boston MedFlight receiving blood products during transport.

NCT ID: NCT04561050 Completed - Bleeding Clinical Trials

Prediction of Massive Transfusion in Trauma Patients

MTP
Start date: August 1, 2020
Phase:
Study type: Observational

Since the 2000s, many prognostic scores were developed to predict traumatic haemorrhage. Most of these studies were retrospectives based on registers. Due to missing data on death due to bleeding, these studies chose to predict the massive transfusion risk as a surrogate of haemorrhagic death. These scores include clinical parameters (vital signs), laboratory values (Haemoglobin, lactate, Base excess) and/or imaging (CT or ultrasound) values. The scores showing best performance are the Trauma Associated Severe Haemorrhage (TASH) score, developed and validated on the German register (DGU-Register) and the ABC score developed and validated in the United States of America. However, the majority of these scores cannot be applied at the trauma scene due to the unavailability of laboratory and imaging values. Therefore, their clinical utility remains unclear. To overcome the need for diagnostic tests, authors have developed and recently validated a clinical prognostic score in identifying trauma patients with, or at risk of, significant haemorrhage based on predicted probabilities of death due to bleeding: BATT score. This score was developed from an international cohort using data from 271 Trauma Centres in 41 countries on 5 continents and uses first clinical parameters at initial assessment. The BATT score predicts death due to bleeding and has been validated on a large population in England and Wales. It could also predict massive transfusion, as a surrogate of haemorrhagic death, earlier at the trauma scene. Its feasibility and external validation would make its clinical utility superior to other scores while identifying a greater number of patients requiring early management. Our study is an external validation of pre-existing prognostic scores of traumatic haemorrhages (TASH , ABC and BATT score) at different times of care (Scene of Injury, admission at the trauma room) in order to assess their overall performance, discrimination and calibration in the prediction of massive transfusion, and haemorrhagic death. The objective of the study is to assess a comparison of score performances (Overall performance, discrimination and calibration). Due to the study population (STR), which is partly integrated into the German DGU-Register, the investigators expect good transportability of the TASH score to the Swiss Trauma Registry in terms of overall performance, discrimination and calibration. The ABC score should show lowers results in terms of discrimination due to its validation on small cohorts exclusively in North America. The new BATT score predicting death due to bleeding has been validated on a large English cohort of more than 100,000 patients. It identifies all patients with haemorrhage and not only patients who have received a massive transfusion subject to survival bias. In this context, the BATT score provides good discrimination with only simple physiological variables available at the trauma scene. In case of its external validation on the STR as part of our study, its feasibility would make its clinical utility superior to other pre-existing scores, while identifying a greater number of patients requiring early management. Its application would activate a massive transfusion plan directly at the trauma scene and save precious time.

NCT ID: NCT04497155 Completed - Clinical trials for Traumatic Brain Injury

Prehospital Norepinephrine and Early Mortality in Traumatic Shock

Start date: January 1, 2013
Phase:
Study type: Observational

The effect of early, prehospital norepinephrine use in patients with traumatic shock on mortality is unknown. Recent existing observational evidence from single system data (US, France, Japan) are conflicting. The investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock.

NCT ID: NCT04331457 Not yet recruiting - Ischemic Stroke Clinical Trials

Predictors Of Stroke Outcome In Chidren

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

Stroke can be defined as an abrupt loss of brain function that is caused by decreased cerebral blood flow. Stroke can occur at all stages of life, but presentation is variable depending on age, involved artery, and underlying risk factors.

NCT ID: NCT04149171 Completed - Hemorrhagic Shock Clinical Trials

Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage

Start date: September 26, 2018
Phase: Phase 3
Study type: Interventional

Study Design: Single-center, not-randomized, open-label, two-arms controlled pilot clinical trial. Health Condition: Patients with severe trauma with a need for transfusion and categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut) Polytrauma Code (PPT)

NCT ID: NCT04019015 Active, not recruiting - Trauma Injury Clinical Trials

Prehospital Kcentra for Hemorrhagic Shock

Start date: March 15, 2021
Phase: Phase 2
Study type: Interventional

This is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field.