Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study

NCT03937947 | Completed

• 2 other identifiers: AC18105WKR0-2018-0020
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Whilst deep vein thrombosis (DVT) is common following traumatic brain injury (TBI), optimal timing and safety of pharmacological prophylaxis is uncertain. Paradoxically the harm associated with the occurrence of is also unclear. This study is an observational pilot that aims to define the incidence of proximal DVT in patients with moderate to severe TBI. It seeks prospectively to determine if there is an association between DVT and outcome. It also seeks to explore possible associations between the occurrence of DVT and the incidence of lung injury and/or ventilator associated pneumonia.

Conditions

Traumatic Brain Injury; Deep Vein Thrombosis; Acute Lung Injury; Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Incidence of proximal DVT by compression ultra sound

  Alternate day compression ultra sound

  within 72 hours of injury until day 10 post injury.

Secondary Outcomes (7)

• Incidence of Acute Lung Injury

  Up to 10 days post injury

• Incidence of Ventilator Associated Pneumonia

  Up to 10 days post injury

• Ventilator days in ICU

  From day of injury until death whilst receiving ventilatory support or no longer requiring actively ventilation or respiratory support greater than the provision of continuous positive airways pressure (CPAP) via a tracheostomy, upto 6 months.

• Length of Stay in ICU

  From day of injury until day of death or discharge from ICU to a step down unit providing level 1 care or lower, upto 6 months.

• Hospital Length of Stay

  From day of injury until day of death or hospital discharge to a rehabilitation facility, nursing facility, or patient's home, assessed upto 6 months.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with moderate to severe TBI requiring critical care support.

You may qualify if:

• Age ≥ 16 years
• Admission to critical care
• moderate/severe, non-penetrating traumatic brain injury
• Abnormal brain CT Scan
• Post resuscitation Glasgow coma score (GCS) ≤12, or GCS motor component ≤5
• Able to complete consent and first USS within 72 hours of injury

You may not qualify if:

• Normal brain CT scan
• Unlikely to survive for the next 24 hours in the opinion of the ICU Consultant or Consultant Neurosurgeon treating the patient
• Contra indication to normal prophylactic measures, including heparin, were indicated
• Known blood clotting disorder or thrombophilia
• Significant pelvic or lower limb trauma
• Malignancy
• Pregnancy or recently post-partum

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Intensive Care Unit, Western General Hospital

Edinburgh, Midlothian, EH42XU, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Venous Thrombosis; Acute Lung Injury; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Intensive Care and Anaesthesia

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 6, 2019
• Study Start: September 28, 2019
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)