Fibrinolysis Resistance in Infection and Trauma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Admission to ICU, needing at least one organ supportand principally for the management of clinically suspected Sepsis or Septic shock according to Spesis-3 criteria (including SARS-COV-2)

• Expected to remain in ICU and survive beyond the day after tomorrow

• Trauma is the principal diagnosis on ICU admission

• Expected to remain in ICU and survive beyond the day after tomorrow

• Receiving respiratory support at the time of ICU admission - high-flow nasal prongs, non-invasive or invasive ventilation

• Already received, or considered at risk of needing a blood product transfusion within 24 hrs of injury

Locations
Other Locations
Australia
The Canberra hospital (ICU)
RECRUITING
Canberra
Liverpool Hospital (ICU)
RECRUITING
Liverpool
Macquarie University Hospital (ICU)
RECRUITING
Macquarie
Royal North Shore Hospital (ICU)
RECRUITING
St Leonards
Contact Information
Primary
Anders Aneman, MD, PhD, EDIC, FCICM
anders.aneman@health.nsw.gov.au
+61427915693
Backup
Lucy Coupland, Nurs Cert, BSci (hons), PhD
lucy.coupland@health.nsw.gov.au
+61419723330
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 150
Treatments
Sepsis/Septic shock
According to Sepsis-3 definitions (including SARS CoV-2 as pathogen); expected to remain in ICU and survive beyond the day after tomorrow and for full, active ICU treatment; arterial and secure venous access established or imminent as part of standard care; not on oral anticoagulant/antiplatelet therapy.
Severe Trauma
Admitted via the Emergency Department resuscitation bay requiring trauma team response; deemed at risk of significant blood loss and where transfusion of blood products i considered in the ED during the acute phase of the resuscitation by a senior clinician; expected to remain in ICH and survive beyond the day after tomorrow and for full, active ICU treatment; Not on oral anticoagulant/antiplatelet therapy. A clinical based inclusion approach is the most pragmatic means of patient selection and can be objectively supported by routine blood tests demonstrating poor oxygen supply to the organs. Exclusion criteria: unsurvivable head injury.
Related Therapeutic Areas
Sponsors
Collaborators: Royal North Shore Hospital, Liverpool Hospital, South Western Sydney Local Health District, The Canberra Hospital, Macquarie University, Australia
Leads: Anders Aneman

This content was sourced from clinicaltrials.gov