A Phase 2 interventional study of Ascorbic Acid Injectable Product and Placebo in Acute Lung Injury, Transfusion Related, sponsored by Damanhour University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Damanhour University · Phase 2, Interventional, and Treatment
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.
All patients will be subjected directly at time of enrollment to the following;
Eighty patients with confirmed TRALI (n=80) will be enrolled from critical care units (tertiary hospitals). Then, in addition to their supportive and standard care, they will be randomized (computer sheet) into two groups:
51 studies on the registry are indexed under Transfusion Reaction; 11 are open to participants now.
This study's enrollment of 40 is below the median of 71 across 21 interventional studies indexed under Transfusion Reaction.
Browse Transfusion Reaction studies →Damanhour University is the lead sponsor of 78 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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;
Exclusion Criteria:
ASTRALI (AScorbic acid in TRALI) group (n=40)
Drug: Ascorbic Acid Injectable Product
Control group (n=40)
Drug: Placebo
Intermittent Intravenous Infusion of Ascorbic Acid (Vitamin C) 2.5 gm / 6 hours for 96 hours
Also known as: Vitamin C
Placebo saline / 6 hours for 96 hours
Also known as: Normal saline
Interleukin-8 (IL-8)
Plasma level of IL-8
Time frame: 96 hrs
Interleukin-10 (IL-10)
Plasma Level of IL-10
Time frame: 96 hrs
C-reactive protein (CRP)
Serum level of CRP
Time frame: 96 hrs
Superoxide Dismutase (SOD)
Plasma Level of SOD
Time frame: 96 hrs
Malondialdehyde (MDA)
Plasma level of MDA
Time frame: 96 hrs
Vasopressor use (days)
Duration of circulatory support
Time frame: up to 28 days
Duration of Mechanical Ventilation (days)
Duration of ventilatory support
Time frame: up to 28 days
ICU length of stay (days)
Length of stay in ICU
Time frame: Up to 28 days
7-days Mortality
All cause mortality
Time frame: 7 days
28-days Mortality
All cause mortality
Time frame: 28 days
Plan to share: No — The summary of all relevant data
Ran from Nov 2019 to primary completion in Jul 2021, 19 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ascorbic Acid
Damanhour University