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Shock, Hemorrhagic clinical trials

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NCT ID: NCT03218722 Completed - Shock, Hemorrhagic Clinical Trials

Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

PROCOAG
Start date: December 29, 2017
Phase: Phase 3
Study type: Interventional

Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP. To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion. ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion. Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.

NCT ID: NCT02924792 Completed - Hemorrhagic Shock Clinical Trials

Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis

Start date: November 2016
Phase: N/A
Study type: Observational

In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated.

NCT ID: NCT02880163 Not yet recruiting - Trauma Clinical Trials

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

REVIVE
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.

NCT ID: NCT02872428 Terminated - Trauma Clinical Trials

A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)

Start date: November 2016
Phase: Phase 1
Study type: Interventional

THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was to determine the safety and tolerability of ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects. ID: VPA-C-002 The second part of the study will also be to determine the safety and tolerability of single ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic shock.

NCT ID: NCT02821364 Withdrawn - Peritonitis Clinical Trials

Philadelphia Immediate Transport in Penetrating Trauma Trial

PIPT
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

PIPT Trial (Philadelphia Immediate Transport in Penetrating Trauma Trial) A prospective randomized clinical trial comparing pre-hospital procedures to immediate transportation in patients with penetrating injury and shock.

NCT ID: NCT02784951 Completed - Hemorrhagic Shock Clinical Trials

Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System

ProHEMS
Start date: January 1, 2016
Phase:
Study type: Observational

The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.

NCT ID: NCT02736812 Completed - Shock Hemorrhagic Clinical Trials

Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO)

PREHO-PLYO
Start date: April 1, 2016
Phase: Phase 3
Study type: Interventional

In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy. Study Design This is a randomized controlled multicenter open label study in two parallel groups. Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood pressure <70 mmHg] or Shock Index >1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment they received.

NCT ID: NCT02535624 Completed - Fractures, Bone Clinical Trials

Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

Start date: February 2003
Phase: N/A
Study type: Interventional

This study is designed to answer whether minimal invasive vessel clotting (angioembolization) or open surgery (retroperitoneal packing) is more effective for pelvic fractures with massive bleeding. Patients admitted at daytime (7am-5pm) are treated with angioembolization while patients admitted at nighttime (5pm to 7am) are treated with open surgery.

NCT ID: NCT02303964 Withdrawn - Shock, Hemorrhagic Clinical Trials

Pre-Hospital Use of Plasma for Traumatic Hemorrhage

PUPTH
Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital. The purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

NCT ID: NCT02111109 Completed - Clinical trials for Traumatic Haemorrhagic Shock

An Observational Pilot Study of the Effects of Traumatic Haemorrhagic Shock and Resuscitation on the Microcirculation

MICROSHOCK
Start date: July 2014
Phase:
Study type: Observational

Haemorrhage following major trauma is an important preventable cause of death. Those patients who survive may have a prolonged period of debility caused by failure of key body organs. We suspect that an important contributor to this organ failure may be dysfunction in the network of small blood vessels that supply the bodies organs with oxygen and nutrients. Our study will examine the link between the microcirculation and organ failure in patients who have suffered significant bleeding after traumatic injury. We will also explore the relationship between resuscitation of the global circulation (blood pressure, cardiac output etc.)an area that is monitored in clinical practice with the state of the microcirculation, which by contrast is not monitored. Patients with severe traumatic injury commonly have problems with blood clotting. Some researchers have suggested that microcirculatory failure may be an important contributor to this problem and we will explore this in more detail. Finally, we will attempt to examine some of the mechanisms by which the microcirculation may be disrupted by trauma and subsequent bleeding. These may include inappropriate activation of white blood cells, inadequate function of oxygen carrying red blood cells and changes to the cells lining the small blood vessels. We will use a non invasive method to assess the microcirculation termed Side Stream Dark Field microscopy. This involves recorded a video image of the movement of blood within the small blood vessels under a patients tongue. In addition we will use ultrasound to assess the flow of blood from the heart. Small samples of blood will be taken to assess blood clotting and to look at possible mechanisms of microcirculatory dysfunction. We aim to study ten patients in the first instance. The study will be carried out within the intensive care units at Kings College Hospital.