Treatment for Exsanguination

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Exsanguination+6 More
Eligibility
Any Age
All Sexes
Eligible conditions
Exsanguination

Study Summary

This study is evaluating whether a foam can help stop bleeding in trauma patients.

See full description

Eligible Conditions

  • Exsanguination
  • Shock
  • Shock, Hemorrhagic
  • Hemorrhage
  • Exsanguinating Hemorrhage
  • Traumas
  • Traumatic Shock

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Exsanguination. Measurement will happen over the course of All SBP assessments prior to deployment of IP through removal of IP and completion of laparotomy. Patient will be followed through hospital discharge or through Day 30, whichever comes first..

Day 30
Change in systolic blood pressure after deployment of ResQFoam over baseline value

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 40 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: all sbp assessments prior to deployment of ip through removal of ip and completion of laparotomy. patient will be followed through hospital discharge or through day 30, whichever comes first.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly all sbp assessments prior to deployment of ip through removal of ip and completion of laparotomy. patient will be followed through hospital discharge or through day 30, whichever comes first. for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
Class III or IV hemorrhagic shock or Assessment of Blood Consumption (ABC) score ≥ 2
Decision to administer foam is made within 30 minutes of admission to the emergency department.
Positive Focused Assessment with Sonography in Trauma (FAST) or Diagnostic Peritoneal Aspiration (DPA)
No other known, uncontrolled active sources of hemorrhage
Subject is intubated and sedated per local guidelines
Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
Definitive surgical care is expected to occur within three hours of foam deployment
Subject must also be receiving concurrent transfusion of fluids or blood products.

Patient Q&A Section

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

What causes exsanguination?

Add answer

Trauma is the single most common cause of death in hospital, occurring more frequently than in industrialized countries. The cause of death can be deduced in the majority of cases by the examination of the wounds alone.

Unverified Answer

What is exsanguination?

Add answer

The data presented indicate that it can be performed with some degree of safety and comfort for patients and that it does not lead to death in emergency department patients. The data indicate that it avoids the need for a prolonged CPR. It may be a useful adjunct to other methods of controlling hemorrhage in this environment.

Unverified Answer

How many people get exsanguination a year in the United States?

Add answer

Approximately 15,000 to 20,000 cases of exsanguination in the US occur annually. This is more than either amputation or death. These data do not reflect all cases of exsanguination in the US, and are confined only to those cases wherein the injuries are minor. The data imply that this form of injury may not be underreported; we discuss the implications of this finding for the current discussion of reporting this type of injury.

Unverified Answer

Can exsanguination be cured?

Add answer

Although it is difficult to prove that in vitro thromboplastin generation is necessary for all cases of exsanguination, our results show that it is a good strategy in cases of low PAI-1 levels in order to maintain platelet counts during the exsanguination procedure in order to avoid bleeding.

Unverified Answer

What are common treatments for exsanguination?

Add answer

The overall best-evidence approach suggests the need to treat wounds at the first stage of hemorrhage using wound dressings in combination with oral rehydration therapy as an adjunct treatment. In advanced bleeding, early use of blood transfusions can also help treat hemorrhage.

Unverified Answer

What are the signs of exsanguination?

Add answer

Symptoms such as chest pains, rapid heartbeat, paleness, low blood pressure, weakness and loss of consciousness indicate exsanguination.\n\nIf a person loses a large amount of blood, this is usually an indication for urgent medical attention, such as being stabilized at a hospital. For a large quantity of bleeding, if a person has not ceased their activities, hospital care is recommended.\n\nAny person is of concern if they experience shortness of breath. Other symptoms include coughing up blood, chest pain, dizziness, headaches, numbness, loss of consciousness and light sensitization.\n\nInjuries and burns occur commonly. Other possible symptoms of accidents include a head injury or pain along the spine.

Unverified Answer

How does treatment work?

Add answer

The [treatments] examined in the article are useful for some cancers and can save a patient's life when other options are not available. Treatments are sometimes harmful unless the right patient is treated at the right time. In some cases, cancer patients may need other treatments because cancer evolves and changes into a more aggressive form. However, each cancer must be treated on its own merits.

Unverified Answer

How serious can exsanguination be?

Add answer

The most serious case of exsanguination is when the extremity is cut above the superficial vasculature with a scalpel. This is a life-threatening event; urgent medical attention should be obtained. Exsanguation was also rare after arterial ligation and injection of blood into the extremities followed by ligation.

Unverified Answer

Who should consider clinical trials for exsanguination?

Add answer

[Some patients with high hemorrhage wish to give up a life to receive a promising new treatment and may need to commit themselves to participating in a clinical trial for exsanguination (http://www.withpower.com/clinical-trials/exsanguination.

Unverified Answer

Is treatment safe for people?

Add answer

The prevalence of complications and risk estimates from all studies was too low to draw meaningful conclusions regarding the safety of treatment. Studies that have been conducted of lower quality tend to report more outcomes of more relevance than other studies. Because the prevalence of major complications remains low, the risks from these complications have been also low and difficult to interpret. The lack of statistical power for more precise estimation of the risks remains a concern.

Unverified Answer

Have there been other clinical trials involving treatment?

Add answer

There are many clinical trials in cancer and oncology. The American Cancer Society suggests that you ask the clinical trials manager to identify the most recent and the most relevant clinical trial with those options already completed and results known for the disease that interest a patient. If a therapeutic option is being proposed in a clinical trial, ask what trials the treatment has been tested in before. Also ask what trials the patient might be eligible for, and ask the specific treatment for how long a patient might be treated before coming back to see them again.

Unverified Answer

What is the primary cause of exsanguination?

Add answer

Asymptomatic hemorrhagic disease accounts for up to 10% of cases. The two major causes with the highest frequency are [severe hemorrhagic disease with thrombosis of small arteries caused by EHDV] and [severe hemorrhagic disease with thrombosis of large arteries with systemic thrombophlebitis of small arteries (VAD syndrome)].

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Exsanguination by sharing your contact details with the study coordinator.