The Activation of Coagulation and Inflammation in Trauma (ACIT) study is designed to identify the clinically significant mechanisms and pathways by which inflammation and coagulation are activated immediately following major trauma, and how these…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Injuries NEC
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
28 day mortality
Secondary outcome
Secondary endpoints:
Blood transfusion requirement in first 24 hours, length of hospital stay, ICU
stay, 28-day ventilator free days, occurrence of acute lung injury (ALI), acute
respiratory distress syndrome (ARDS), acute kidney injury (AKI) and multiple
organ failure (MOF)
Background summary
Trauma is the leading cause of death and disability in children and young
adults. Over half of all trauma deaths are due to bleeding or the complications
resulting from it.[1] Injury, shock and blood loss all contribute to a failure
of the body*s normal blood clotting mechanisms (coagulation), which then leads
to more bleeding. The mechanisms of these disorders in blood clotting, what
initiates them, and how they affect the body are not well understood.
Study objective
The Activation of Coagulation and Inflammation in Trauma (ACIT) study is
designed to identify the clinically significant mechanisms and pathways by
which inflammation and coagulation are activated immediately following major
trauma, and how these result in the observed clinical sequelae of this in terms
of bleeding, transfusion requirements, organ injury, multiple organ failure and
death.
Study design
Multicenter prospective cohort study.
Study burden and risks
There is no potential benefit for the research participants. The risk to
incapacitated adults is no greater than that to adult trauma patients able to
give consent, and the study specifically pertains to this group of more
severely injured trauma patients. We expect the study to cause a minimum of
discomfort to participants.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Trauma patients for whom a full trauma team activation is given
Exclusion criteria
* Age <18
* Patients transferred from other hospitals
* Patients presenting more than 120 minutes after time of injury
* Patients who have received more than 2000 mL of intravenous fluids prior to emergency department arrival
* Patients with burns >5% of their body surface area
* Patients taking anticoagulant medication other than aspirin (<650mg/day)
* Patients with a known bleeding diathesis
* Patients with moderate to severe liver disease (Child's classification B or C)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38900.018.11 |