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Shock, Hemorrhagic clinical trials

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NCT ID: NCT02071290 Completed - Hemorrhagic Shock Clinical Trials

Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.

NCT ID: NCT01973504 Withdrawn - Trauma Clinical Trials

Phase 2c Dose Comparison Study of MP4OX in Trauma

Start date: December 2013
Phase: Phase 2
Study type: Interventional

MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.

NCT ID: NCT01951560 Completed - Shock,Hemorrhagic Clinical Trials

A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1)

Start date: September 2013
Phase: Phase 1
Study type: Interventional

The purpose of the first part of this study is 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. 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: NCT01838863 Terminated - Trauma Clinical Trials

Control of Major Bleeding After Trauma Study

COMBAT
Start date: April 7, 2014
Phase: Phase 2
Study type: Interventional

Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.

NCT ID: NCT01780129 Not yet recruiting - Shock, Septic Clinical Trials

Polydatin Injectable (HW6) for Shock Treatment

PIST
Start date: February 2013
Phase: Phase 2
Study type: Interventional

HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac function, improves microcirculation, and increases blood pressure and pulse pressure, and improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined multiple target pharmacological effects. Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock patient. This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure stabilization, regardless the types of completed, on-going, or projected Standard of Care or surgery will be recruited to participant in the trial. A total of 120 patients with traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each type of shock, sixty patients each will be in test group and control group. Both adult males and females aged 18-80 years are eligible. The primary clinical endpoint is the time length (TL) between the start of HW6 administration to the onset of the first treatment success, that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressors. Several secondary endpoints and biomarkers will be measured. Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment groups and placebo groups. Safety data will also be reported accordingly.

NCT ID: NCT01741818 Completed - Hemorrhagic Shock Clinical Trials

The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States

Start date: April 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.

NCT ID: NCT01676454 Withdrawn - Injury Clinical Trials

Serum Vasopressin Levels and Severe Hemorrhagic Shock

Start date: November 2012
Phase:
Study type: Observational

The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).

NCT ID: NCT01433276 Completed - Hemorrhagic Shock Clinical Trials

Efficacy, Safety of Solution Containing Hyperosmolar Sodium Lactate Infusion for Resuscitation of Patients With Hemorrhagic Shock

Start date: July 2009
Phase: Phase 3
Study type: Interventional

Indication: Resuscitation in pts with hemorrhagic shock due to multiple injuries Prospective, open label RCT in pts. with traumatic hemorrhagic shock in RS Hasan Sadikin Hospital, Indonesia. PI: Dr. Kiki Lukman, PsBD(K), Surgery, RSHS. Co-PI: (late)Prof. Xavier Leverve MD, PhD, Directeur, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier, France Hemorrhagic shock is a cause of death in trauma.Fluid resuscitation to ensure stable hemodynamics and microcirculation by rapidly restoring circulating plasma volume could be a cornerstone of managing trauma patients. Excessive fluid accumulation particularly in the interstitial tissue should be avoided. Hypertonic solution shows promise in restoring intravascular volume expansion and microcirculation with less fluid infusion in hypovolemic patients. This study investigated efficacy and safety of hyperosmolar Na lactate(Totilac®) for resuscitating traumatic hemorrhagic shock patients. Patients with multiple injuries with grade III hemorrhagic shock and RTS ≥4 received std initial fluid resuscitation of upto 2 liters of isotonic crystalloid. They also got similar dose of either hyperosmolar Na lactate or ringer's lactate. Hemodynamic status, fluid balance and and safety was recorded during the study.

NCT ID: NCT01411852 Completed - Hemorrhagic Shock Clinical Trials

Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma

HypoResus
Start date: March 2012
Phase: Phase 2
Study type: Interventional

Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation. Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.

NCT ID: NCT01262196 Completed - Shock, Traumatic Clinical Trials

Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

Start date: May 2011
Phase: Phase 2
Study type: Interventional

MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.