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

September 9, 2019 updated by: King's College Hospital NHS Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom
        • Royal London Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • University Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with traumatci injury, haemorrhae and impaired perfusion

Description

Inclusion Criteria History of traumatic injury received blood products prior to ICU admission

Exclusion Criteria:

Not expected to survive 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traumatic injury
Device: Side Stream Dark Field Microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SOFA score
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 28 days
28 days
Length of ICU stay
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Collaborators

University Hospital Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 13, 2017

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/YH/0078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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