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CompletedNCT02111109MICROSHOCKUpdated Sep 11, 2019

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

An observational study in Traumatic Haemorrhagic Shock, sponsored by King's College Hospital NHS Trust. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by King's College Hospital NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
58
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Traumatic Haemorrhagic Shock

Keywords

  • Microcirculation
  • Trauma
  • Haemorrhage
  • Shock
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In context

Shock

917 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's enrollment of 58 is below the median of 92 across 347 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 165 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with traumatci injury, haemorrhae and impaired perfusion

Eligibility criteria

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

Exclusion Criteria:

Not expected to survive 24 hours

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Traumatic injury

    Device: Side Stream Dark Field Microscopy

Interventions

  • DeviceSide Stream Dark Field Microscopy
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What researchers measure

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

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Study locations

3 sites
  • University Hospital Birmingham
    Birmingham, West Midlands, United Kingdom
  • Kings College Hospital
    London, SE5 9RS, United Kingdom
  • Royal London Hospital
    London, United Kingdom
08

References and documents

Publications

  • Naumann DN, Hazeldine J, Midwinter MJ, Hutchings SD, Harrison P. Poor microcirculatory flow dynamics are associated with endothelial cell damage and glycocalyx shedding after traumatic hemorrhagic shock. J Trauma Acute Care Surg. 2018 Jan;84(1):81-88. doi: 10.1097/TA.0000000000001695. PubMed 28885470 ↗
  • Naumann DN, Mellis C, Smith IM, Mamuza J, Skene I, Harris T, Midwinter MJ, Hutchings SD. Safety and feasibility of sublingual microcirculation assessment in the emergency department for civilian and military patients with traumatic haemorrhagic shock: a prospective cohort study. BMJ Open. 2016 Dec 21;6(12):e014162. doi: 10.1136/bmjopen-2016-014162. PubMed 28003301 ↗
  • Hutchings S, Naumann DN, Harris T, Wendon J, Midwinter MJ. Observational study of the effects of traumatic injury, haemorrhagic shock and resuscitation on the microcirculation: a protocol for the MICROSHOCK study. BMJ Open. 2016 Mar 4;6(3):e010893. doi: 10.1136/bmjopen-2015-010893. PubMed 26944694 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02111109
Lead sponsor
King's College Hospital NHS Trust
Collaborators
University Hospital Birmingham
Responsible party
Sponsor
First posted
Apr 10, 2014
Start date
Jul 2014
Primary completion
May 2017
Completion
Jun 13, 2017
Last update
Sep 11, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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