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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early changes in blood activity after a severe injury can predict complications such as SIRS (a serious inflammatory response) during recovery. Researchers will collect additional blood samples through venipuncture or fingerstick from trauma and surgical patients to monitor these changes. The trial seeks participants who are trauma patients, undergoing invasive surgeries with high blood loss, or healthy volunteers without chronic conditions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance recovery outcomes for future patients.

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.

What prior data suggests that blood draws are safe for patients?

Research shows that taking blood, either with a needle in a vein or a small prick on the finger, is generally safe. Most people handle these methods well. The main side effects are usually minor, such as a small bruise or temporary soreness at the site.

Some people might feel lightheaded, especially if they dislike needles, but serious problems are rare. Blood draws are a routine part of medical care and occur safely every day in hospitals and clinics. They help monitor health, check medical conditions, and gather data for research, making them a standard practice in both medical and research settings.

For any concerns about the blood draw process, discussing them with the medical staff can help ease worries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a method to monitor the acute phase response to injuries or surgeries through blood draws. Unlike standard practices that may not offer frequent and comprehensive tracking, this approach allows for detailed monitoring by collecting blood samples at multiple time points, from pre-surgery or admission, through the post-operative or recovery period. This can provide insights into how the body responds to trauma or surgery over time, potentially improving our understanding of recovery and leading to more personalized care strategies.

What evidence suggests that this blood draw monitoring is effective for assessing acute phase response post-injury?

Research has shown that taking blood samples is a common and safe method to understand how the body reacts to injury or surgery. In this trial, researchers will collect blood samples from participants in different groups: those undergoing invasive elective surgery, trauma patients, and healthy volunteers. Studies have found that blood samples can help identify inflammation and other changes in the body after trauma. This is crucial because early signs of inflammation can lead to serious problems like SIRS (systemic inflammatory response syndrome) and TIC (trauma-induced coagulopathy). Blood samples enable doctors to monitor these risks and manage them more effectively. While blood samples do not treat these conditions, they provide essential information that guides treatment decisions. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan Schoenecker, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Trauma Patients Experimental Treatment 1 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 Patients Experimental Treatment 1 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 Volunteers Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK97517/

Diagnostic venepuncture: systematic review of adverse events A systematic review was carried out in order to identify studies reporting adverse events in adults undergoing simple venepuncture for diagnostic or screening ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1541461224000892

Strategic Integration of Technology and Practice Model ... This case study details an evolution in blood draw practice at a US acute care hospital, informed by in-depth semi-structured interviews with hospital leaders.

3. scholarworks.waldenu.edu scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=17437&context=dissertations

Clinical Practice Guideline on Evaluating the Effectiveness of ... In this project, the environmental factors that affect phlebotomy outcomes were combined with a targeted, evidence-based educational ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05878483?term=Vitestro&rank=1

Autonomous Blood Drawing Optimization and Performance ... The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7047503/

Promoting appropriate utilisation of laboratory tests for ... These characteristics make CRP the preferred test for detecting acute phase inflammation in patients with undiagnosed conditions. Simultaneous ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK115275/bin/appg-et8.pdf

G.4.2 Safety needles – phlebotomy Limitations: Survey data not obtained from all. HCW – response rate only 60% for one question. Additional outcomes: Under reporting rates of PI by profession.

7. osha.gov osha.gov/sites/default/files/publications/OSHA3404laboratory-safety-guidance.pdf

Laboratory Safety Guidance The standard monitoring device is a clip-on badge or ring badge bearing the individual assignee's name, date of the monitoring period and a unique ...

8. fda.gov fda.gov/patients/drug-development-process/step-3-clinical-research

Step 3: Clinical Research Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop ...

9. ema.europa.eu ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e19-selective-approach-safety-data-collection-specific-late-stage-pre-approval-or-post-approval-clinical-trials-step5_en.pdf

ich-guideline-e19-selective-approach-safety-data-collection ... This document describes circumstances in which it may be appropriate to reduce the collection of safety data in late-stage pre-approval and post ...

10. openstax.org openstax.org/books/clinical-nursing-skills/pages/10-4-blood-sampling

10.4 Blood Sampling - Clinical Nursing Skills Nurses collect blood samples from patients using several methods, including venipuncture, capillary blood sampling, and blood draws from venous ...