NCT03741023

Brief Summary

The purpose of the proposed study is to test these hypotheses through the following aims:

  1. 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. 2.To determine if early plasmin activation following severe injury correlates with plasminogen consumption and poor plasmin activity later in convalescence.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2019Dec 2027

First Submitted

Initial submission to the registry

October 31, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7.1 years

First QC Date

October 31, 2018

Last Update Submit

March 23, 2026

Conditions

Acute Phase Response

Outcome Measures

Primary Outcomes (3)

  • Interleukin-6 (IL-6)

    A change in Interleukin-6 (IL-6) lab value following traumatic injuries or traumatic elective surgeries will be used to determine change in systematic inflammation.

    During hospitalization (approximately 7-21 days)

  • Thrombin-Antithrombin (TAT) Complex

    A change in the Thrombin-antithrombin (TAT) complex following traumatic injuries or traumatic elective surgeries will be used to determine change in coagulation.

    During hospitalization (approximately 7-21 days)

  • D-Dimer

    A change in d-dimer lab value following traumatic injuries or traumatic elective surgeries will be used to determine change in fibrinolysis.

    During hospitalization (approximately 7-21 days)

Study Arms (3)

Trauma Patients

OTHER

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.

Procedure: Blood draw (venipuncture or fingerstick)

Invasive Elective Surgery Patients

OTHER

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.

Procedure: Blood draw (venipuncture or fingerstick)

Healthy Volunteers

OTHER

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.

Procedure: Blood draw (venipuncture or fingerstick)

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.

Healthy VolunteersInvasive Elective Surgery PatientsTrauma Patients

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient admitted to or treated in the VUMC Adult Trauma Unit
  • Patients ages 16 and older (all included in the adult trauma unit admissions)
  • Patients will be divided into sub-groups for analyses based on type of trauma (TBI, blunt force trauma, polytrauma, etc) and severity (Level 1 vs non-level 1 trauma)

You may not qualify if:

  • None
  • Any patient admitted for an invasive elective surgery associated with high blood loss or a high risk of vascular complications at VUMC/VCH. Enrollment will be at the discretion of the attending physician
  • This may include, but is not limited to, orthopedic and vascular surgery patients
  • None
  • Volunteers should be male or female
  • Age 18-70 years of age
  • Weight greater than 110lbs
  • Chronic medical conditions such as: diabetes, hypertension, high cholesterol, rheumatologic disorders, infections, etc.
  • No history of recent traumatic injury (within the past year)
  • Pregnant females or people on hormone replacement therapy
  • People on any anticoagulant medication or NSAIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Univeristy Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Gibson BHY, Duvernay MT, McKeithan LJ, Benvenuti TA, Warhoover TA, Martus JE, Mencio GA, Emerson BR, Moore-Lotridge SN, Borst AJ, Schoenecker JG. Variable Response to Antifibrinolytics Correlates with Blood-loss and Transfusion in Posterior Spinal Fusion. Spine Deform. 2022 Jul;10(4):841-851. doi: 10.1007/s43390-022-00489-6. Epub 2022 Mar 5.

    PMID: 35247191DERIVED

MeSH Terms

Conditions

Acute-Phase Reaction

Interventions

Blood Specimen CollectionPhlebotomy

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesTherapeutics

Study Officials

  • Jonathan Schoenecker, MD, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopaedic Surgery, Associate Professor of Pediatrics

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 14, 2018

Study Start

December 12, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)