NCT07490314

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 9, 2026

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

The COVID-19 pandemic is contributing to delays in blood product acquisition and inadequate blood product supplies for emergent cases in hospitals

future policies on use of blood products from COVID-19-positive donors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \<18 years of age Prisoners Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center- Clinical Research Institute

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jennifer Burris, Pharm D

    Methodist Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

March 24, 2026

Study Start

March 1, 2020

Primary Completion

March 21, 2021

Study Completion

June 25, 2025

Last Updated

March 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Not mentioned in protocol
Access Criteria
Not mentioned in protocol

Locations