Hemorrhagic Shock Clinical Trial
Official title:
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. a Pilot Trial
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)
Major hemorrhage in the setting of severe trauma patient is associated with significant morbidity and mortality. Hemorrhage is compounded by trauma induced coagulopathy of which hypo/dysfibrinogenemia and hypoperfusion play a significant role. There is a good evidence to suggest that hypofibrinogenemia in trauma is associated with worse outcomes and it is postulated that early replacement of fibrinogen and red blood cells packages may reduce hemorrhage and improve outcomes even in the pre-hospital phase of care. In this pilot study, the investigators will try to prove the feasibility and efficacy of managing the severe traumatic patient with red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate compared to standard treatment based on crystalloid fluid and TXA in the pre-hospital phase of care. Early administration at pre-hospital phase of care of RBC, FC and TXA is feasible , secure and can help controlling trauma induced coagulopathy. Better outcomes in terms of mortality, less transfusion requirements and less crystalloid administration is expected ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06070350 -
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
|
Phase 3 | |
| Not yet recruiting |
NCT02880163 -
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
|
N/A | |
| Completed |
NCT02924792 -
Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis
|
N/A | |
| Terminated |
NCT00750997 -
Hypertonic Modulation of Inflammation Following Injury
|
N/A | |
| Terminated |
NCT03477006 -
Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial
|
Phase 3 | |
| Not yet recruiting |
NCT04987411 -
Detection of Exhaled Methane Levels in Hemorrhagic Shock
|
||
| Recruiting |
NCT04610814 -
Blood Transfusion by Boston MedFlight Registry
|
||
| Completed |
NCT02071290 -
Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock
|
N/A | |
| Completed |
NCT03535441 -
HMGB1 Release From Hemorrhagic Shock Patients
|
||
| Completed |
NCT03480555 -
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients
|
N/A | |
| Completed |
NCT03402035 -
Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)
|
||
| Completed |
NCT05081063 -
Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
|
Phase 3 | |
| Recruiting |
NCT03235921 -
Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock
|
Phase 2 | |
| Active, not recruiting |
NCT03469947 -
California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA
|
Phase 3 | |
| Completed |
NCT01411852 -
Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
|
Phase 2 | |
| Withdrawn |
NCT01221389 -
Study Using Plasma for Patients Requiring Emergency Surgery
|
Phase 4 | |
| Recruiting |
NCT03406598 -
Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients
|
||
| Completed |
NCT00328133 -
The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry
|
N/A | |
| Completed |
NCT00379522 -
Vasopressin in Traumatic Hemorrhagic Shock Study
|
Phase 2/Phase 3 | |
| Completed |
NCT01433276 -
Efficacy, Safety of Solution Containing Hyperosmolar Sodium Lactate Infusion for Resuscitation of Patients With Hemorrhagic Shock
|
Phase 3 |