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

NCT02111109 | Completed

• 1 other identifier: 14/YH/0078
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Traumatic Haemorrhagic Shock

Keywords

Microcirculation; Trauma; Haemorrhage; Shock

Outcome Measures

Primary Outcomes (1)

• SOFA score

  72 hours

Secondary Outcomes (2)

• Length of ICU stay

  28 days

• Mortality

  28 days

Study Arms (1)

Traumatic injury

Device: Side Stream Dark Field Microscopy

Interventions

Side Stream Dark Field Microscopy DEVICE

Traumatic injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with traumatci injury, haemorrhae and impaired perfusion

You may not qualify if:

• Not expected to survive 24 hours

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• University Hospital Birmingham: collaborator

Study Sites (3)

University Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 28885470 DERIVED

• 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.

  PMID: 28003301 DERIVED

• 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.

  PMID: 26944694 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood / plasma / urine

MeSH Terms

Conditions

Wounds and Injuries; Hemorrhage; Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: June 13, 2017
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

GB (3)