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Blood Draw Monitoring for Acute Phase Response Post-Injury

N/A

Waitlist Available

Led By Jonathan Schoenecker, MD, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight greater than 110lbs

Age 18-70 years of age

Must not have

People on any anticoagulant medication or NSAIDS

Pregnant females or people on hormone replacement therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospitalization (approximately 7-21 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if early plasmin activation following severe injury correlates with complications later in convalescence.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves standard procedures like blood draws via venipuncture or fingerstick, side effects may include temporary discomfort at the puncture site, bruising, bleeding, or fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh more than 110lbs.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking blood thinners or anti-inflammatory drugs.

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I am pregnant or on hormone replacement therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during hospitalization (approximately 7-21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during hospitalization (approximately 7-21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization (approximately 7-21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

D-Dimer

Interleukin-6 (IL-6)

Thrombin-Antithrombin (TAT) Complex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met