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Blood Draw Monitoring for Acute Phase Response Post-Injury

Q: Is this trial currently recruiting participants?

<p>Per the information on clinicaltrials.gov, this trial is not actively recruiting at present. The study was first made available to participants on December 12th 2019 and its details were last modified February 21st 2022. Though individuals are unable to join this medical experiment currently, there are two more research projects that do have open enrollment windows right now.</p>

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

Patients ages 2 months and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospitalization (approximately 7-21 days)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 at least 2 months old.

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I may need or have had orthopedic or vascular surgery.

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I am admitted for a surgery with high risk of blood loss or vascular issues, as decided by my doctor.

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I am 16 years old or older.

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I am either male or female.

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I am between 18 and 70 years old.

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My injury is categorized by its type and how severe it is.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

D-Dimer

Interleukin-6 (IL-6)

Thrombin-Antithrombin (TAT) Complex

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

671,872 Total Patients Enrolled

Jonathan Schoenecker, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center

1 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Invasive Elective Surgery Patients Clinical Trial Eligibility Overview. Trial Name: NCT03741023 — N/A

Acute Phase Response Research Study Groups: Invasive Elective Surgery Patients, Trauma Patients, Healthy Volunteers

Acute Phase Response Clinical Trial 2023: Invasive Elective Surgery Patients Highlights & Side Effects. Trial Name: NCT03741023 — N/A

Invasive Elective Surgery Patients 2023 Treatment Timeline for Medical Study. Trial Name: NCT03741023 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently recruiting participants?

"Per the information on clinicaltrials.gov, this trial is not actively recruiting at present. The study was first made available to participants on December 12th 2019 and its details were last modified February 21st 2022. Though individuals are unable to join this medical experiment currently, there are two more research projects that do have open enrollment windows right now."

Answered by AI

Recent research and studies

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Disorders of the Acute Phase Response Following Trauma and Invasive Surgery

Jon Schoenecker 2019. "Disorders of the Acute Phase Response Following Trauma and Invasive Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03741023.