Disorders of the Acute Phase Response Following Trauma and Invasive Surgery

Conditions

• Acute Phase Response

Eligibility Criteria

Sex

ALL

Age

2 Months - N/A

Healthy Volunteers

Accepted

Interventions

• Blood draw (venipuncture or fingerstick) — PROCEDURE
  Blood will be drawn from participants by venipuncture and/or by fingerstick. Finger sticks will not be collected in the pediatric population.

Study Details

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.

Key Dates

Start date

Dec 12, 2019

Status verified

Mar 2026

Primary completion

Jan 1, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

320 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Other: Trauma Patients
  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.
• Other: Invasive Elective Surgery Patients
  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.
• Other: Healthy Volunteers
  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.

Primary Outcome Measure

Interleukin-6 (IL-6) [ Time Frame: During hospitalization (approximately 7-21 days) ]

Locations (1)

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