By InvitationNot Applicable

Disorders of the Acute Phase Response Following Trauma and Invasive Surgery

United States320 participantsStarted 2019-12-12

Plain-language summary

The purpose of the proposed study is to test these hypotheses through the following aims: 1. To determine if early plasmin activation following severe injury correlates with SIRS, TIC and complications throughout convalescence in both trauma and surgical patients. 2. To determine if early plasmin activation following severe injury correlates with plasminogen consumption and poor plasmin activity later in convalescence.

Who can participate

Age range

2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Arm 1: Level I Trauma Patients Inclusion criteria * Any patient admitted to or treated in the VUMC Adult Trauma Unit * Patients ages 16 and older (all included in the adult trauma unit admissions) * Patients will be divided into sub-groups for analyses based on type of trauma (TBI, blunt force trauma, polytrauma, etc) and severity (Level 1 vs non-level 1 trauma) Exclusion criteria • None Arm 2: Invasive Elective Surgical Patients Inclusion criteria * Any patient admitted for an invasive elective surgery associated with high blood loss or a high risk of vascular complications at VUMC/VCH. Enrollment will be at the discretion of the attending physician * This may include, but is not limited to, orthopedic and vascular surgery patients * Patients ages 2 months and older Exclusion criteria * None Arm 3: Healthy Volunteers Inclusion criteria * Volunteers should be male or female * Age 18-70 years of age * Weight greater than 110lbs Exclusion criteria * Chronic medical conditions such as: diabetes, hypertension, high cholesterol, rheumatologic disorders, infections, etc. * No history of recent traumatic injury (within the past year) * Pregnant females or people on hormone replacement therapy * People on any anticoagulant medication or NSAIDS

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Interleukin-6 (IL-6)

Timeframe: During hospitalization (approximately 7-21 days)

Thrombin-Antithrombin (TAT) Complex

Timeframe: During hospitalization (approximately 7-21 days)

D-Dimer

Timeframe: During hospitalization (approximately 7-21 days)

Trial details

NCT IDNCT03741023

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

View on ClinicalTrials.gov More Acute Phase Response trials

Plain-language summary

Who can participate

Age range

2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.