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Brief Summary

TRALI was defined as "acute noncardiogenic pulmonary edema typically occurs ≤ 6 hours following transfusion of plasma-containing blood products, such as packed red blood cells, fresh frozen plasma, platelets, or cryoprecipitate." In critically ill patients, TRALI remains the leading cause of transfusion-related fatalities and is accompanied by a very significant morbidity and mortality. Survival in such patients is as low as 53% compared with 83% in acute lung injury (ALI) controls. The incidence of TRALi is likely underreported. In densely populated developing countries, incidence has not decreased due to lack of male-only strategy for plasma donation. TRALI is associated with systemic inflammation characterized by low anti-inflammatory cytokine as interleukin (IL)-10, increased pro-inflammatory cytokine as IL-8. Regulation of inflammation should include avoidance of overproduction of inflammatory mediators. So, it can be dampened not only by increasing IL-10 but also by decreasing IL-1β release. C-reactive protein (CRP) is an acute phase protein which is up-regulated during infections and inflammation. CRP was recently identified as a novel first hit in TRALI. Till now, there is no established treatment for TRALI beyond supportive care and monitoring. Recently, potential therapies have been reviewed, and it was concluded that the most promising therapeutic strategies are IL-10 therapy, downregulation of CRP levels, targeting reactive oxygen species (ROS) or blocking IL-8 receptors. So, antioxidants (such as high dose vitamins), were recommended for future studies as potentially effective treatment. Vitamin C hypovitaminosis is observed in 70% of critically ill despite receiving recommended daily doses. The aim of this study is to investigate the role of intravenous vitamin C (ascorbic acid) as a targeted therapy for transfusion related acute lung injury (TRALI) in critically ill patients in terms of IL-8, IL-10, CRP, SOD, malondialdehyde (MDA), vasopressor use, duration of mechanical ventilation, ICU length of stay, 7-days mortality and 28-days mortality.

Conditions

Acute Lung Injury, Transfusion Related

Keywords

Transfusion ReactionTransfusion Related ComplicationAcute Lung InjuryCritical Care

Outcome Measures

Primary Outcomes (5)

Interleukin-8 (IL-8)
Plasma level of IL-8
96 hrs
Interleukin-10 (IL-10)
Plasma Level of IL-10
96 hrs
C-reactive protein (CRP)
Serum level of CRP
96 hrs
Superoxide Dismutase (SOD)
Plasma Level of SOD
96 hrs
Malondialdehyde (MDA)
Plasma level of MDA
96 hrs

Secondary Outcomes (5)

Vasopressor use (days)
up to 28 days
Duration of Mechanical Ventilation (days)
up to 28 days
ICU length of stay (days)
Up to 28 days
7-days Mortality
7 days
28-days Mortality
28 days

Study Arms (2)

ASTRALI Group

EXPERIMENTAL

ASTRALI (AScorbic acid in TRALI) group (n=40)

Drug: Ascorbic Acid Injectable Product

Control Group

PLACEBO COMPARATOR

Control group (n=40)

Drug: Placebo

Interventions

Ascorbic Acid Injectable ProductDrug

Intermittent Intravenous Infusion of Ascorbic Acid (Vitamin C) 2.5 gm / 6 hours for 96 hours

Also known as: Vitamin C

ASTRALI Group

PlaceboDrug

Placebo saline / 6 hours for 96 hours

Also known as: Normal saline

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Ascorbic Acid Injectable Product
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Ascorbic Acid Injectable Product
Named ingredient: Ascorbic acid
View registry record

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Adult (18 - 64 years) critically ill patients diagnosed with transfusion related acute lung injury (TRALI), at the time of enrollment or maximum 6 hours before, according to the National Heart, Lung and Blood Institute (NHLBI) Working Group definitions and or the Canadian Consensus Conference criteria (29, 30) as the following criteria;

Sponsors & Collaborators

Alexandria University
Othercollaborator
Damanhour University
Otherlead

Study Sites (1)

Damanhour University

Beheira, 22511, Egypt

Related Publications (37)

Peters AL, Van Stein D, Vlaar AP. Antibody-mediated transfusion-related acute lung injury; from discovery to prevention. Br J Haematol. 2015 Sep;170(5):597-614. doi: 10.1111/bjh.13459. Epub 2015 Apr 28.
PMID: 25921271BACKGROUND
Vlaar AP, Juffermans NP. Transfusion-related acute lung injury: a clinical review. Lancet. 2013 Sep 14;382(9896):984-94. doi: 10.1016/S0140-6736(12)62197-7. Epub 2013 May 1.
PMID: 23642914BACKGROUND
Roubinian N. TACO and TRALI: biology, risk factors, and prevention strategies. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):585-594. doi: 10.1182/asheducation-2018.1.585. Epub 2018 Dec 14.

MeSH Terms

Conditions

Transfusion-Related Acute Lung InjuryTransfusion ReactionAcute Lung Injury

Interventions

Ascorbic AcidSaline Solution

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, Acyclic

Study Officials

Gamal A Omran, PHD
Professor of Biochemistry, Damanhour University.
STUDY DIRECTOR
Mohamed M Megahed, MD
Professor of Critical Care Medicine, Alexandria University.
STUDY DIRECTOR
Tamer N Zakhary, MD
Ass. Professor of Critical Care Medicine, Alexandria University.
STUDY CHAIR
Amira B Kassem, PHD
Lecturer of Clinical Pharmacy, Damanhour University.
STUDY CHAIR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Masking Details: single (participant)
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 6, 2019

Study Start

November 30, 2019

Actual (reported)

Role of Ascorbic Acid Infusion in Critically Ill Patients With Transfusion Related Acute Lung Injury

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (2)

ASTRALI Group

Control Group

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (37)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (2)

ASTRALI Group

Control Group

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (37)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations