Prothrombin Complex Concentrate, Human for Shock, Hemorrhagic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Oregon Health & Science University, Portland, OR
Shock, Hemorrhagic+2 More
Prothrombin Complex Concentrate, Human - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a drug called Kcentra can be used to treat people who are in shock.

See full description

Eligible Conditions

  • Shock, Hemorrhagic
  • Trauma Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Shock, Hemorrhagic

Study Objectives

This trial is evaluating whether Prothrombin Complex Concentrate, Human will improve 1 primary outcome and 5 secondary outcomes in patients with Shock, Hemorrhagic. Measurement will happen over the course of First 30 days after injury.

Hour 24
Blood Transfusions
Feasibility of study drug administration
Day 30
Hospital Free Days
ICU Free Days
Mortality
Ventilator Free Days

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Shock, Hemorrhagic

Trial Design

2 Treatment Groups

Kcentra
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 166 total participants across 2 different treatment groups

This trial involves 2 different treatments. Prothrombin Complex Concentrate, Human is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Kcentra
Drug
A single dose of Kcentra based on estimated body weight 2000 U for patients with an estimated body weight ≤ 75kg 3000 U for patients with an estimated body weight > 75kg
Placebo
Drug
A single infusion of volume matched placebo solution (Normal Saline)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first 24 hours after injury
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly first 24 hours after injury for reporting.

Who is running the study

Principal Investigator
M. A. S.
Prof. Martin A Schreiber, MD
Oregon Health and Science University

Closest Location

Oregon Health & Science University - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
EMS transport to a participating trauma center
The text states that trauma patients who are 18 years or older, or who weigh more than 50 kg, if the patient's age is unknown, will be given morphine. show original
Systolic blood pressure < 70 mmHg
The patient may have suffered from hemorrhagic shock if their injury was caused by a sudden bleeding. show original

Patient Q&A Section

What are the signs of shock, hemorrhagic?

"To prevent and treat shock in severely injured patients, we need to know what shock looks like and if our nurses can recognise it, particularly how to differentiate between the subtle signs that are more easily overlooked: in our research a high accuracy rate (86%) was achieved both in the prediction of shock status and detecting the magnitude of blood flow. Although a combination of clinical and laboratory tests is optimal in detecting shock, our nurses can add the vital information of heart rate to their repertoire in identifying shock." - Anonymous Online Contributor

Unverified Answer

What causes shock, hemorrhagic?

"shock has diverse causes including infection, injury, and disease. Hemorrhagic shock also has a complex pathophysiology, however the two are usually thought to be different entities. The underlying mechanisms in shock are often not understood (e.g., cytokine cascade) or have been poorly studied.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for shock, hemorrhagic?

"The current care for resuscitating those who have undergone trauma or other trauma may be outdated and/or be ineffective. Further investigation is needed to determine the safest, most efficacious, and most cost-effective method to resuscitate those with shock." - Anonymous Online Contributor

Unverified Answer

How many people get shock, hemorrhagic a year in the United States?

"Each year, around 80,000 people in the US are hospitalized for shock, hemorrhage, or massive transfusion. This makes up around 0.5% of American adults. This article is a U.S. Government work and is in the public domain in the USA." - Anonymous Online Contributor

Unverified Answer

Can shock, hemorrhagic be cured?

"Data from a recent study demonstrated that shock in patients with severe hemorrhage leading to DIC, can be treated and not necessarily lead to death. The combination of hemofiltration, the use of blood products, and blood transfusion in shock has contributed to this success." - Anonymous Online Contributor

Unverified Answer

What is shock, hemorrhagic?

"In the U.S., 5,080 people died from shock-associated hemorrhage in 2011. Deaths due to shock and hemorrhage were the third and fourth most common cause of death from cardiovascular disease in 2011, respectively. In the United States, shock is associated with significant mortality and a major source of mortality, and the mortality and morbidity that arise from shock-associated hemorrhage." - Anonymous Online Contributor

Unverified Answer

How does prothrombin complex concentrate, human work?

"The authors found that they could not draw a conclusion on the efficacy to treat hemorrhage due to lack of statistical power and the large variability between the studies, the small number of treated patients, and the different types of PCC." - Anonymous Online Contributor

Unverified Answer

Has prothrombin complex concentrate, human proven to be more effective than a placebo?

"Prothrombin complex, when used for management of blunt hemorrhage, does not appear to be more effective than the comparator. The number of patients in this study is too low to allow conclusions about prothrombin complex's overall effectiveness in this setting." - Anonymous Online Contributor

Unverified Answer

Is prothrombin complex concentrate, human safe for people?

"PCC is a human (and animal) product and has a significant potential for transmission of prions such as Creutzfeldt-Jakob disease. No PCC transfusion-related cases of primate virus diseases have been reported to date. Despite this, PCC is regarded as safe, and the risks from inadvertent transfusion of PCCs are theoretically minimal given the lack of prion risk." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in prothrombin complex concentrate, human for therapeutic use?

"The development of PCCs was marked by the ongoing use of animal-derived products for the treatment of thrombotic disorders and a progressive refinement of the product in human and its use for prophylaxis in a wide range of thrombotic conditions. The emergence of PCCs in our present setting in the form of PCCa (pCCa + rFVIIa) has provided a further advance in our ability to manage most emergency medical conditions associated with thrombotic disorders and will greatly improve on current management standards." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of prothrombin complex concentrate, human?

"Patients in our group had no adverse reactions from prothrombin complex concentrates. There were few adverse effects noted among non-adverse events seen. Adverse reactions were similar in incidence among healthy control and clinical patients. Adverse reactions were not attributed to prothrombin complex concentrates. Prothrombin complex concentrates can be used safely in routine therapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of shock, hemorrhagic?

"Primary causes of shock include sepsis and multiple organ dysfunction with diffuse endotoxemia (MOAD). The shock of MOAD can be secondary to a reduction in blood supply to the body, as from [trauma, surgery, anemia, blood loss, arterial embolism, septic shock, or coagulopathy (disordered blood clotting)(DOAC/DOA, DOAC, DOA, DHA)]. As MOAD is an umbrella term for several diseases, any shock that is not secondary to MOAD also may be [secondary to MOAD, and is not necessarily a direct consequence of an underlying disorder (DOAC/DOA, DOAC, OR DAA)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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