Traumatic Haemorrhagic ShockMICROSHOCKNCT02111109
An Observational Pilot Study of the Effects of Traumatic Haemorrhagic Shock and Resuscitation on the Microcirculation
An observational study of Traumatic Haemorrhagic Shock, run by King's College Hospital NHS Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Haemorrhagic Shock
- What is being tested?
- Side Stream Dark Field Microscopy
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2014to 13 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with traumatci injury, haemorrhae and impaired perfusion
Who may be able to join
None listed.
Who cannot join
- Not expected to survive 24 hours
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospital Birmingham
Birmingham, West Midlands
Kings College Hospital
London, SE5 9RS
Royal London Hospital
London
About this study
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.
- Conditions
- Traumatic Haemorrhagic Shock
- Being tested
- Side Stream Dark Field Microscopy
- Keywords
- Microcirculation, Trauma, Haemorrhage, Shock
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side Stream Dark Field MicroscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Traumatic injury | Not described Receives: Device: Side Stream Dark Field Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score
Measured: 72 hours
Secondary outcomes (2)
Length of ICU stay
Measured: 28 days
Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Haemorrhagic ShockStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111109
- Sponsor's protocol ID
- 14/YH/0078
- Acronym
- MICROSHOCK
- Status last verified
- Sep 2019
- First submitted
- 8 Apr 2014
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
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 28885470Naumann 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 28003301Hutchings 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Pilot Study of the Effects of Traumatic Haemorrhagic Shock and Resuscitation on the Microcirculation
- ClinicalTrials.gov ID
- NCT02111109
- Acronym / sponsor ID
- MICROSHOCK / 14/YH/0078
- Conditions
- Traumatic Haemorrhagic Shock
- Keywords
- Microcirculation, Trauma, Haemorrhage, Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- Jul 2014
- Primary completion
- May 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic injury | – | Device: Side Stream Dark Field Microscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatci injury, haemorrhae and impaired perfusion
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Not expected to survive 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Side Stream Dark Field Microscopy | Device | Traumatic injury |
Primary outcome
SOFA score
Time frame: 72 hours
2 secondary outcomes
Length of ICU stay
Time frame: 28 days
Mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 28885470Naumann 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.
- Derived from this study: PubMed 28003301Naumann 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.
- Derived from this study: PubMed 26944694Hutchings 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Haemorrhagic Shock, run by King's College Hospital NHS Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA score (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111109, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.