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Disorders of the Acute Phase Response Following Trauma and Invasive Surgery

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ClinicalTrials.gov Identifier: NCT03741023
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jon Schoenecker, Vanderbilt University Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Phase Response Procedure: Blood draw (venipuncture or fingerstick) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Disorders of the Acute Phase Response Accelerated by Plasmin Activation Following Trauma and Invasive Surgery: A Prospective Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Follow-Up Visits During routine care visits, we would like to obtain blood via one finger stick. A maximum of one blood draw via finger stick would be collected per month by research personnel, for up to two years.

Procedure: Blood draw (venipuncture or fingerstick)
Blood will be drawn from participants by venipuncture or by fingerstick.

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 (2 blue-top tubes) 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 (~3% total blood volume).

Follow-Up Visits During routine care visits, we would like to obtain blood via one finger stick. A maximum of one blood draw via finger stick would be collected per month, for up to two years.

Procedure: Blood draw (venipuncture or fingerstick)
Blood will be drawn from participants by venipuncture or by fingerstick.

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.
Procedure: Blood draw (venipuncture or fingerstick)
Blood will be drawn from participants by venipuncture or by fingerstick.




Primary Outcome Measures :
  1. Interleukin-6 (IL-6) [ Time Frame: During hospitalization (approximately 7-21 days) and at follow-up visits (approximately 2 years from injury/surgery). ]
    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.

  2. Thrombin-Antithrombin (TAT) Complex [ Time Frame: During hospitalization (approximately 7-21 days) and at follow-up visits (approximately 2 years from injury/surgery). ]
    A change in the Thrombin-antithrombin (TAT) complex following traumatic injuries or traumatic elective surgeries will be used to determine change in coagulation.

  3. D-Dimer [ Time Frame: During hospitalization (approximately 7-21 days) and at follow-up visits (approximately 2 years from injury/surgery). ]
    A change in d-dimer lab value following traumatic injuries or traumatic elective surgeries will be used to determine change in fibrinolysis.



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Arm 1: Level I Trauma Patients Inclusion criteria

  • 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) Exclusion criteria
  • None

Arm 2: Invasive Elective Surgical Patients Inclusion criteria

  • 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
  • Patients ages 7 years and older

Exclusion criteria

• None

Arm 3: Healthy Volunteers Inclusion criteria

  • Volunteers should be male or female
  • Age 18-70 years of age
  • Weight greater than 110lbs

Exclusion criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741023


Locations
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United States, Tennessee
Vanderbilt Univeristy Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Jonathan Schoenecker, MD, PhD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Jon Schoenecker, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] October 25, 2018


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Responsible Party: Jon Schoenecker, Associate Professor of Orthopaedic Surgery, Associate Professor of Pediatrics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03741023     History of Changes
Other Study ID Numbers: 181982
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute-Phase Reaction
Inflammation
Pathologic Processes