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NCT Number: NCT02111109

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Birmingham, Birmingham, West Midlands, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History of traumatic injury received blood products prior to ICU admission

Exclusion criteria

Not expected to survive 24 hours

Treatment and study plan

Side Stream Dark Field Microscopy

Device

Primary outcomes

  1. SOFA score

    Time frame: 72 hours

Secondary outcomes

  1. Length of ICU stay

    Time frame: 28 days

  2. Mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • University Hospital Birmingham

Registry information

Acronym: MICROSHOCK

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2014
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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