ACIT-2: An observational study investigating the systemic inflammatory, coagulation and genomic response in humans to severe injury and bleeding after major trauma

A prospective, observational study investigating the molecular and cellular responses to traumatic injury (and resuscitation) in severely injured and bleeding adults and children and how these influence patient outcomes such as mortality, organ dysfunction, blood transfusion requirements and quality of life: Activation of Coagulation and Inflammation in Trauma II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12962642

Enrollment

5000

Registered

2021-03-31

Start date

2008-01-23

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molecular and cellular responses to traumatic injury in severely injured adults and children Injury, Occupational Diseases, Poisoning

Interventions

Participants are enrolled at pre-hospital (Adults) or in the Emergency Department (Adults and Children). Patient data will be collected for the first 28 days and blood samples will be taken for first

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All trauma patients regardless of age can be screened for inclusion in hospital (adults only in prehospital care)

Exclusion criteria

Exclusion criteria: 1. Transfers from other hospitals 2. Burns >5% total body surface area 3. More than 120 min have lapsed since time of injury 4. Deemed inappropriate for recruitment by an independent clinician

Design outcomes

Primary

Measure	Time frame
Measured using patient records throughout the study: 1. Blood products transfused in the first 24 hours 2. Incidence & severity of acute organ injury & MODS	—

Secondary

Measure	Time frame
Measured using patient records throughout the study: 1. 28-day mortality 2. Ventilator-free days 3. Length of hospital and critical care stay 4. Thrombotic events 5. Requirement for organ support (artificial ventilation, renal replacement therapy, inotropic support) 6. Infection – organ-specific and each episode detailed 7. Transfer destination at discharge e.g. home, other medical facility, rehabilitation unit 8. Quality of life at 28 days and 1 year measured using EQ5D questionnaire and extended Glasgow Outcome Scale (adults); added 04/04/2025: and PedsQL (children)	—

Measure

Time frame

Measured using patient records throughout the study: 1. 28-day mortality 2. Ventilator-free days 3. Length of hospital and critical care stay 4. Thrombotic events 5. Requirement for organ support (artificial ventilation, renal replacement therapy, inotropic support) 6. Infection – organ-specific and each episode detailed 7. Transfer destination at discharge e.g. home, other medical facility, rehabilitation unit 8. Quality of life at 28 days and 1 year measured using EQ5D questionnaire and extended Glasgow Outcome Scale (adults); added 04/04/2025: and PedsQL (children)

—

Countries

England, United Kingdom

Contacts

Public ContactCharlotte Lindsay

c.lindsay@qmul.ac.uk+44 (0)2035 940728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026