Effect of Severe Trauma on PD1 and Its Legend (PD1/L1) on T Lymphocytes and Correlation With Mortality

NCT04233723 | Unknown

• 1 other identifier: IRB171000017
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Unlike neuro-endocrine response to trauma; posttraumatic immune alterations are not easily carried out at bedside. The majority of trials were conducted in the intensive care usually hours to days post injury. In this trial the investigators sought assess the immune responses during emergency department trauma resuscitation by looking at the biomarkers of severe injury by comparing T lymphocytes and programmed cell death molecules and its relation with mortality.

Conditions

Trauma Patients

Outcome Measures

Primary Outcomes (1)

• Measuring standard deviations of biomarkers of severe injury by comparing T lymphocytes and programmed cell death molecules and its relation with mortality.

  Results for normally distributed continuous variables will be expressed as mean value, standard deviation and inter-quartile range. Categorical data and dichotomous variables will be shown as number and percentage. Comparisons of continuous variables will be performed using independent t-test. Proportions will be compared with chi-square test.

  48 hours

Interventions

peripheral blood samples OTHER

venous puncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

trauma emergency department and Trauma ICU of Assiut university hospital.

You may qualify if:

• Adult trauma patients with blunt or penetrating injury.
• Major injury:
• Injury severity score \> 15
• Drop in hematocrit \> 10 points
• Transfusion of more than 6-10 units of packed RBCs
• Serum lactate \> 3 mmol/L
• Mean arterial blood pressure ≤ 60 mmHg and/or systolic arterial blood pressure ≤ 90 mmHg.
• Patients admitted to the ED within 6 hours after the onset of trauma

You may not qualify if:

• \- 1. age less than 18 years; 2. patients who died within 2 days of the onset of trauma; 3. patients who declined to consent; 4. Known pregnancy. 5. Patients with limb ischemia or peripheral vascular occlusion. 6. Patients admitted to the emergency trauma department after 6 hours of the trauma event.
• \. Preexisting conditions as severe cardiovascular disease, uncontrolled hemorrhage.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Engelberg-Kulka H, Amitai S, Kolodkin-Gal I, Hazan R. Bacterial programmed cell death and multicellular behavior in bacteria. PLoS Genet. 2006 Oct;2(10):e135. doi: 10.1371/journal.pgen.0020135.

  PMID: 17069462 BACKGROUND

• Islam N, Whitehouse M, Mehendale S, Hall M, Tierney J, O'Connell E, Blom A, Bannister G, Hinde J, Ceredig R, Bradley BA. Post-traumatic immunosuppression is reversed by anti-coagulated salvaged blood transfusion: deductions from studying immune status after knee arthroplasty. Clin Exp Immunol. 2014 Aug;177(2):509-20. doi: 10.1111/cei.12351.

  PMID: 24749651 BACKGROUND

• Murray CK, Hinkle MK, Yun HC. History of infections associated with combat-related injuries. J Trauma. 2008 Mar;64(3 Suppl):S221-31. doi: 10.1097/TA.0b013e318163c40b.

  PMID: 18316966 BACKGROUND

• Kaczmarek A, Vandenabeele P, Krysko DV. Necroptosis: the release of damage-associated molecular patterns and its physiological relevance. Immunity. 2013 Feb 21;38(2):209-23. doi: 10.1016/j.immuni.2013.02.003.

  PMID: 23438821 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral venous blood samples

Study Officials

• Ramy R Hennis

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramy R Hennis, MD

CONTACT

01094703771; ramtragaie80@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: January 18, 2020
• Study Start: April 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share