Traumatic Haemorrhagic Shock Clinical Trial
— MICROSHOCK| NCT number | NCT02111109 |
| Other study ID # | 14/YH/0078 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2014 |
| Est. completion date | June 13, 2017 |
| Verified date | September 2019 |
| Source | King's College Hospital NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | June 13, 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria History of traumatic injury received blood products prior to ICU
admission Exclusion Criteria: Not expected to survive 24 hours |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospital Birmingham | Birmingham | West Midlands |
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | Royal London Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| King's College Hospital NHS Trust | University Hospital Birmingham |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SOFA score | 72 hours | ||
| Secondary | Length of ICU stay | 28 days | ||
| Secondary | Mortality | 28 days |