Blood Product Supply

Blood Product Supply During COVID-19

Data about the links between Coronavirus disease 2019(COVID-19) and the safety of blood products during the pandemic is inadequate. During the COVID-19 pandemic, high volumes of patients receiving blood products due to post-terminal surgical complications depleted stores for the entire hospital, resulting in surgeons unable to acquire emergent blood products. Data from this study can be used to develop a policy on how to handle blood shortage issues during this and future pandemics. Also, this data can be used to determine future policies on use of blood products from COVID-19-positive donors.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Document delays and frequencies of inadequate blood products for emergent cases

Detailed Description

• To identify the circumstances associated with observed delays in receiving blood products to use in emergent cases.
• Determine the cost/benefit of moribund patients receiving massive transfusion during the COVID-19 pandemic.
• Quantify COVID-19 diagnosis and complications in patients arriving with no indication of disease at index admission as relative to in hospital or blood product exposure.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center- Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients typically present with fever, nonproductive cough, dyspnea, myalgia, and/or fatigue. The main cause of death in COVID-19 patients is acute respiratory distress syndrome(ARDS). ARDS is caused by a cytokine storm that triggers an attack on the body by pro-inflammatory cytokines and chemokines, eventually resulting in multiple organ failure and death.

Description

Inclusion Criteria:

>_18 years of age Surgical patients treated at Methodist Dallas Medical Center(MDMC)

Exclusion Criteria:

<18 years of age Prisoners Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
future policies on use of blood products from COVID-19-positive donors; Data from this study can be used to develop a policy on how to handle blood shortage issues during this and future pandemics.	Other: Document delays and frequencies of inadequate blood products for emergent cases; The COVID-19 pandemic is contributing to delays in blood product acquisition and inadequate blood product supplies for emergent cases in hospitals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time frame	Dates of inadequate or delayed blood products for emergent cases during the timeframe of the COVID-19 pandemic (March 2020 to March 2021) to be compared relative to number of days or cases where no shortages were noted	1 year

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Jennifer Burris, Pharm D, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 21, 2021
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 045.TRA.2020.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of Protected Health Information(PHI) or research information. Only de-identified PHI will be shared in relevant research mediums. The data will be presented at local, regional, national, and international sites. The research gathered will be analyzed and submitted to relevant peer-reviewed medical journals for publication to add to the body of knowledge in the science community. All institutional identifiers will be removed prior to presentation.
• IPD Sharing Time Frame: Not mentioned in protocol
• IPD Sharing Access Criteria: Not mentioned in protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No