Apply to Trial

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

Blood Draw Monitoring for Acute Phase Response Post-Injury

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Diabetes, Hypertension, High cholesterol, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

If you are a healthy volunteer, you cannot participate if you are taking anticoagulant medication or NSAIDs. For trauma or surgical patients, the protocol does not specify if you need to stop your current medications.

Is blood draw generally safe for humans?

Blood draws, whether by fingerstick or venipuncture (using a needle in the arm), are generally safe, but can sometimes cause a vasovagal reaction (a temporary drop in heart rate and blood pressure leading to fainting) or, rarely, nerve injury.¹ ² ³ ⁴ ⁵

How does this treatment for acute phase response post-injury differ from other treatments?

This treatment is unique because it focuses on monitoring blood draws to observe the acute phase response, which is an early defense system activated by injury. Unlike other treatments that might directly target symptoms or complications, this approach aims to understand the body's natural healing process and immune response after an injury.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

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.

Research Team

Jonathan Schoenecker, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for patients aged 2 months to 70 years who are undergoing high-risk surgery or have been admitted to the trauma unit. They must weigh over 110lbs and not be on anticoagulants, NSAIDs, hormone therapies, or have chronic conditions like diabetes.

Inclusion Criteria

I weigh more than 110lbs.

I am at least 2 months old.

I may need or have had orthopedic or vascular surgery.

See 5 more

Exclusion Criteria

No history of recent traumatic injury (within the past year)

I am taking blood thinners or anti-inflammatory drugs.

I am pregnant or on hormone replacement therapy.

See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hospitalization

Patients have blood drawn pre-, intra-, and post-operatively, and at regular intervals during hospitalization for analysis

7-21 days

Multiple visits (in-person)

Follow-up

Any complications resulting from surgery or traumatic injury will be documented at routine care visits

2 years

Routine care visits

Treatment Details

Interventions

Blood draw (venipuncture or fingerstick)

Trial Overview The study aims to understand if early activation of a blood protein called plasmin after severe injury relates to systemic inflammatory responses, clotting issues, and complications during recovery in both surgical and trauma patients.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Trauma PatientsExperimental Treatment1 Intervention

During Hospitalization: Patients routinely have blood drawn at time of admission and every 12 hours following admission up until 2 weeks post-admission or until discharge. Remnants of the blood draw will be stored in the Vanderbilt Lab core and retrieved for further analysis by key research personnel. Patients will have an additional 5.2ml of blood drawn (2 blue-top tubes) per time point during their normal course of care for this study, for a total of 72.8 mL of blood drawn per week. In addition to the routine blood draws, a finger stick may also be obtained the same day. Approximately 3 drops of blood (100μL maximum) will be removed by the finger stick.. Finger sticks will not be collected in the pediatric population. Follow-Up Visits Any complications resulting from traumatic injury will be documented at these routine care visits. These complications will be documented if they occur within 2 years of injury.

Group II: Invasive Elective Surgery PatientsExperimental Treatment1 Intervention

During Hospitalization: Patients routinely have blood drawn pre-, intra- and post-operatively. Remnants of the blood draw will be stored in the Vanderbilt Lab core and retrieved for further analysis by key research personnel. Patients will have an additional 5.2ml of blood drawn (for patients 7 years of age or older) or 2mL of blood drawn (for patients under the age of 7 years old) immediately prior to surgery, every 30 minutes intraoperatively, every 6 hours for 3 days post-operatively, and every 12 hours from 3 days post-operative until discharge. Total blood volume drawn within one week will not exceed 150mL for patients ≥7 years of age and 55mL for patients \<7 years of age (\~3% total blood volume). Follow-Up Visits Any complications resulting from surgery will be documented at these routine care visits. These complications will be documented if they occur within 2 years of surgery.

Group III: Healthy VolunteersExperimental Treatment1 Intervention

Blood will be taken from healthy, non-pregnant adults who weigh at least 110 pounds by research staff trained in venipuncture at a one-time study visit.