Acute Lung Injury, Transfusion RelatedPhase 2ASTRALINCT04153487
Role of Ascorbic Acid Infusion in Critically Ill Patients With Transfusion Related Acute Lung Injury
A Phase 2 study testing Ascorbic Acid Injectable Product in people with Acute Lung Injury, Transfusion Related, run by Damanhour University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acute Lung Injury, Transfusion Related
- What is being tested?
- Ascorbic Acid Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2019to 16 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
- No evidence of ALI prior to transfusion.
- Onset of ALI ≤ 6 hours following cessation of transfusion.
- Hypoxemia, defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or oxygen saturation ≤ 90% on room air.
- Radiographic evidence of bilateral infiltrates.
- No evidence of left atrial hypertension.
Who cannot join
- Pregnancy or breastfeeding.
- Hypernatremia or known hypersensitivity to the study drug.
- Parenteral nutrition (total/partial) containing vitamin C.
- Active renal stone or history of urolithiasis.
- Acute Kidney Injury.
- Glucose 6 phosphate dehydrogenase deficiency, iron and copper storage diseases.
Show all 9Show fewer
- Immunocompromised patients (cancer or patients on immunosuppressive drugs).
- Moribund patient not expected to survive 24 hours .
- Home mechanical ventilation (via tracheotomy or noninvasive) except for Continuous Positive Airway Pressure/ Bilevel Positive Airway Pressure (CPAP/BIPAP) used only for sleep-disordered breathing .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- The minimum required sample size is estimated to be 40 patients for each group.
- Full written informed consent will be taken from all patients or their next of kin to participate in this study.
- All patients will be subjected directly at time of enrollment to the following;
- Complete history taking and demographic data
- The potential recipient risk factors for TRALI.
- The initial cause of ICU admission and the blood products received.
- Complete physical examination including chest auscultations.
- Vital signs
- Routine laboratory investigations
- Brain natriuretic peptide level
- Troponin T
- Hypoxic index
- Acute Physiology and Chronic Health Evaluation version II (APACHE II) score.
- Sequential Organ Failure Assessment (SOFA) score.
- Kidney Disease Improving Global Outcomes (KDIGO) criteria.
- Child Pugh score.
- Chest radiography and transthoracic echocardiography.
- Samples will be drawn to measure the initial values of ascorbate level, plasma IL-8, IL-10, IL-1β, SOD, MDA and serum CRP.
- 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:
- ASTRALI (AScorbic acid in TRALI) group (n=40) will receive 2.5 gm vitamin C intravenously every 6 hrs for 96 hrs from diagnosis.
- Control group (n=40) will receive placebo in similar regimen.
- All patients will be followed up and treated during the study time. All relevant routine investigations, supportive measures, medications and ventilatory data will be recorded.
- All possible adverse events will be monitored, recorded and managed directly. Hyperoxaluria, microscopic calcium-oxalate crystallization or oxalate nephropathy will be monitored, recorded and managed directly.
- After 96 hrs, resampling for ascorbate level and the same biomarkers will be done.
- Measuring the study secondary outcomes will include vasopressor use, duration of mechanical ventilation, ICU length of stay, 7-days mortality and 28-days mortality.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Conditions
- Acute Lung Injury, Transfusion Related
- Being tested
- Ascorbic Acid Injectable Product, Placebo
- Keywords
- Transfusion Reaction, Transfusion Related Complication, Acute Lung Injury, Critical Care
- Medical subject headings
- Transfusion-Related Acute Lung Injury, Transfusion Reaction, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid Injectable ProductDrug
Also called Vitamin C
Intermittent Intravenous Infusion of Ascorbic Acid (Vitamin C) 2.5 gm / 6 hours for 96 hours
PlaceboDrug
Also called Normal saline
Placebo saline / 6 hours for 96 hours
| Study group | Role | What they receive |
|---|---|---|
| ASTRALI Group | Experimental | ASTRALI (AScorbic acid in TRALI) group (n=40) Receives: Drug: Ascorbic Acid Injectable Product |
| Control Group | Placebo comparator | Control group (n=40) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-8 (IL-8)
Plasma level of IL-8
Measured: 96 hrs
Interleukin-10 (IL-10)
Plasma Level of IL-10
Measured: 96 hrs
C-reactive protein (CRP)
Serum level of CRP
Measured: 96 hrs
Superoxide Dismutase (SOD)
Plasma Level of SOD
Measured: 96 hrs
Malondialdehyde (MDA)
Plasma level of MDA
Measured: 96 hrs
Secondary outcomes (5)
Vasopressor use (days)
Duration of circulatory support
Measured: up to 28 days
Duration of Mechanical Ventilation (days)
Duration of ventilatory support
Measured: up to 28 days
ICU length of stay (days)
Length of stay in ICU
Measured: Up to 28 days
7-days Mortality
All cause mortality
Measured: 7 days
28-days Mortality
All cause mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start30 Nov 2019
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Acute Lung Injury, Transfusion RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor
- Investigators
- Gamal A Omran, PHD, Study director, Professor of Biochemistry, Damanhour University.Mohamed M Megahed, MD, Study director, Professor of Critical Care Medicine, Alexandria University.Tamer N Zakhary, MD, Study chair, Ass. Professor of Critical Care Medicine, Alexandria University.Amira B Kassem, PHD, Study chair, Lecturer of Clinical Pharmacy, Damanhour University.Islam E Ahmed, PharmD, Principal investigator, Clinical Pharmacy Specialist, Damanhour University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153487
- Sponsor's protocol ID
- ASTRALI
- Acronym
- ASTRALI
- Status last verified
- May 2021
- First submitted
- 2 Nov 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The summary of all relevant data
Publications
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.
PubMed 25921271Vlaar 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.
PubMed 23642914Roubinian 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.
PubMed 30570487Peters AL, van Hezel ME, Juffermans NP, Vlaar AP. Pathogenesis of non-antibody mediated transfusion-related acute lung injury from bench to bedside. Blood Rev. 2015 Jan;29(1):51-61. doi: 10.1016/j.blre.2014.09.007. Epub 2014 Sep 20.
PubMed 25277811Andreu G, Boudjedir K, Muller JY, Pouchol E, Ozier Y, Fevre G, Gautreau C, Quaranta JF, Drouet C, Rieux C, Mertes PM, Clavier B, Carlier M, Sandid I. Analysis of Transfusion-Related Acute Lung Injury and Possible Transfusion-Related Acute Lung Injury Reported to the French Hemovigilance Network From 2007 to 2013. Transfus Med Rev. 2018 Jan;32(1):16-27. doi: 10.1016/j.tmrv.2017.07.001. Epub 2017 Jul 15.
PubMed 28864336Vlaar AP, Binnekade JM, Prins D, van Stein D, Hofstra JJ, Schultz MJ, Juffermans NP. Risk factors and outcome of transfusion-related acute lung injury in the critically ill: a nested case-control study. Crit Care Med. 2010 Mar;38(3):771-8. doi: 10.1097/CCM.0b013e3181cc4d4b.
PubMed 20035217Vlaar APJ, Toy P, Fung M, Looney MR, Juffermans NP, Bux J, Bolton-Maggs P, Peters AL, Silliman CC, Kor DJ, Kleinman S. An update of the transfusion-related acute lung injury (TRALI) definition. Transfus Clin Biol. 2019 Nov;26(4):354-356. doi: 10.1016/j.tracli.2019.05.007. Epub 2019 Jun 12. No abstract available.
PubMed 31221537Toy P, Gajic O, Bacchetti P, Looney MR, Gropper MA, Hubmayr R, Lowell CA, Norris PJ, Murphy EL, Weiskopf RB, Wilson G, Koenigsberg M, Lee D, Schuller R, Wu P, Grimes B, Gandhi MJ, Winters JL, Mair D, Hirschler N, Sanchez Rosen R, Matthay MA; TRALI Study Group. Transfusion-related acute lung injury: incidence and risk factors. Blood. 2012 Feb 16;119(7):1757-67. doi: 10.1182/blood-2011-08-370932. Epub 2011 Nov 23.
PubMed 22117051Semple JW, Rebetz J, Kapur R. Transfusion-associated circulatory overload and transfusion-related acute lung injury. Blood. 2019 Apr 25;133(17):1840-1853. doi: 10.1182/blood-2018-10-860809. Epub 2019 Feb 26.
PubMed 30808638Roubinian NH, Looney MR, Kor DJ, Lowell CA, Gajic O, Hubmayr RD, Gropper MA, Koenigsberg M, Wilson GA, Matthay MA, Toy P, Murphy EL; TRALI Study Group. Cytokines and clinical predictors in distinguishing pulmonary transfusion reactions. Transfusion. 2015 Aug;55(8):1838-46. doi: 10.1111/trf.13021. Epub 2015 Feb 23.
PubMed 25702590Semple JW, McVey MJ, Kim M, Rebetz J, Kuebler WM, Kapur R. Targeting Transfusion-Related Acute Lung Injury: The Journey From Basic Science to Novel Therapies. Crit Care Med. 2018 May;46(5):e452-e458. doi: 10.1097/CCM.0000000000002989.
PubMed 29384784Ducharme-Crevier L, Lacroix J. Interleukin-1 Receptor Antagonist and Interleukin-1beta: Risk Marker or Risk Factor for Pediatric Acute Respiratory Distress Syndrome? Pediatr Crit Care Med. 2018 Oct;19(10):993-995. doi: 10.1097/PCC.0000000000001713. No abstract available.
PubMed 30281566Pepys MB, Hirschfield GM. C-reactive protein: a critical update. J Clin Invest. 2003 Jun;111(12):1805-12. doi: 10.1172/JCI18921. No abstract available.
PubMed 12813013Kapur R, Kim M, Shanmugabhavananthan S, Liu J, Li Y, Semple JW. C-reactive protein enhances murine antibody-mediated transfusion-related acute lung injury. Blood. 2015 Dec 17;126(25):2747-51. doi: 10.1182/blood-2015-09-672592. Epub 2015 Oct 9.
PubMed 26453659Kapur R, Kim M, Rondina MT, Porcelijn L, Semple JW. Elevation of C-reactive protein levels in patients with transfusion-related acute lung injury. Oncotarget. 2016 Nov 22;7(47):78048-78054. doi: 10.18632/oncotarget.12872.
PubMed 27793007
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ascorbic Acid Infusion in Critically Ill Patients With Transfusion Related Acute Lung Injury
- ClinicalTrials.gov ID
- NCT04153487
- Acronym / sponsor ID
- ASTRALI / ASTRALI
- Conditions
- Acute Lung Injury, Transfusion Related
- Keywords
- Transfusion Reaction, Transfusion Related Complication, Acute Lung Injury, Critical Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- The minimum required sample size is estimated to be 40 patients for each group.
- Full written informed consent will be taken from all patients or their next of kin to participate in this study.
- All patients will be subjected directly at time of enrollment to the following;
- Complete history taking and demographic data
- The potential recipient risk factors for TRALI.
- The initial cause of ICU admission and the blood products received.
- Complete physical examination including chest auscultations.
- Vital signs
- Routine laboratory investigations
- Brain natriuretic peptide level
- Troponin T
- Hypoxic index
- Acute Physiology and Chronic Health Evaluation version II (APACHE II) score.
- Sequential Organ Failure Assessment (SOFA) score.
- Kidney Disease Improving Global Outcomes (KDIGO) criteria.
- Child Pugh score.
- Chest radiography and transthoracic echocardiography.
- Samples will be drawn to measure the initial values of ascorbate level, plasma IL-8, IL-10, IL-1β, SOD, MDA and serum CRP.
- 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:
- ASTRALI (AScorbic acid in TRALI) group (n=40) will receive 2.5 gm vitamin C intravenously every 6 hrs for 96 hrs from diagnosis.
- Control group (n=40) will receive placebo in similar regimen.
- All patients will be followed up and treated during the study time. All relevant routine investigations, supportive measures, medications and ventilatory data will be recorded.
- All possible adverse events will be monitored, recorded and managed directly. Hyperoxaluria, microscopic calcium-oxalate crystallization or oxalate nephropathy will be monitored, recorded and managed directly.
- After 96 hrs, resampling for ascorbate level and the same biomarkers will be done.
- Measuring the study secondary outcomes will include vasopressor use, duration of mechanical ventilation, ICU length of stay, 7-days mortality and 28-days mortality.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| ASTRALI Group | Experimental | Drug: Ascorbic Acid Injectable ProductASTRALI (AScorbic acid in TRALI) group (n=40) |
| Control Group | Placebo comparator | Drug: PlaceboControl group (n=40) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding.
- Hypernatremia or known hypersensitivity to the study drug.
- Parenteral nutrition (total/partial) containing vitamin C.
- Active renal stone or history of urolithiasis.
- Acute Kidney Injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic Acid Injectable ProductAlso: Vitamin CIntermittent Intravenous Infusion of Ascorbic Acid (Vitamin C) 2.5 gm / 6 hours for 96 hours | Drug | ASTRALI Group |
| PlaceboAlso: Normal salinePlacebo saline / 6 hours for 96 hours | Drug | Control Group |
Primary outcome
Interleukin-8 (IL-8)
Time frame: 96 hrs
Plasma level of IL-8
Interleukin-10 (IL-10)
Time frame: 96 hrs
Plasma Level of IL-10
C-reactive protein (CRP)
Time frame: 96 hrs
Serum level of CRP
Superoxide Dismutase (SOD)
Time frame: 96 hrs
Plasma Level of SOD
Malondialdehyde (MDA)
Time frame: 96 hrs
Plasma level of MDA
5 secondary outcomes
Vasopressor use (days)
Time frame: up to 28 days
Duration of Mechanical Ventilation (days)
Time frame: up to 28 days
ICU length of stay (days)
Time frame: Up to 28 days
7-days Mortality
Time frame: 7 days
28-days Mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 25921271Peters 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.
- Background: PubMed 23642914Vlaar 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.
- Background: PubMed 30570487Roubinian 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.
- Background: PubMed 25277811Peters AL, van Hezel ME, Juffermans NP, Vlaar AP. Pathogenesis of non-antibody mediated transfusion-related acute lung injury from bench to bedside. Blood Rev. 2015 Jan;29(1):51-61. doi: 10.1016/j.blre.2014.09.007. Epub 2014 Sep 20.
- Background: PubMed 28864336Andreu G, Boudjedir K, Muller JY, Pouchol E, Ozier Y, Fevre G, Gautreau C, Quaranta JF, Drouet C, Rieux C, Mertes PM, Clavier B, Carlier M, Sandid I. Analysis of Transfusion-Related Acute Lung Injury and Possible Transfusion-Related Acute Lung Injury Reported to the French Hemovigilance Network From 2007 to 2013. Transfus Med Rev. 2018 Jan;32(1):16-27. doi: 10.1016/j.tmrv.2017.07.001. Epub 2017 Jul 15.
- Background: PubMed 20035217Vlaar AP, Binnekade JM, Prins D, van Stein D, Hofstra JJ, Schultz MJ, Juffermans NP. Risk factors and outcome of transfusion-related acute lung injury in the critically ill: a nested case-control study. Crit Care Med. 2010 Mar;38(3):771-8. doi: 10.1097/CCM.0b013e3181cc4d4b.
- Background: PubMed 31221537Vlaar APJ, Toy P, Fung M, Looney MR, Juffermans NP, Bux J, Bolton-Maggs P, Peters AL, Silliman CC, Kor DJ, Kleinman S. An update of the transfusion-related acute lung injury (TRALI) definition. Transfus Clin Biol. 2019 Nov;26(4):354-356. doi: 10.1016/j.tracli.2019.05.007. Epub 2019 Jun 12. No abstract available.
- Background: PubMed 22117051Toy P, Gajic O, Bacchetti P, Looney MR, Gropper MA, Hubmayr R, Lowell CA, Norris PJ, Murphy EL, Weiskopf RB, Wilson G, Koenigsberg M, Lee D, Schuller R, Wu P, Grimes B, Gandhi MJ, Winters JL, Mair D, Hirschler N, Sanchez Rosen R, Matthay MA; TRALI Study Group. Transfusion-related acute lung injury: incidence and risk factors. Blood. 2012 Feb 16;119(7):1757-67. doi: 10.1182/blood-2011-08-370932. Epub 2011 Nov 23.
- Background: PubMed 30808638Semple JW, Rebetz J, Kapur R. Transfusion-associated circulatory overload and transfusion-related acute lung injury. Blood. 2019 Apr 25;133(17):1840-1853. doi: 10.1182/blood-2018-10-860809. Epub 2019 Feb 26.
- Background: PubMed 25702590Roubinian NH, Looney MR, Kor DJ, Lowell CA, Gajic O, Hubmayr RD, Gropper MA, Koenigsberg M, Wilson GA, Matthay MA, Toy P, Murphy EL; TRALI Study Group. Cytokines and clinical predictors in distinguishing pulmonary transfusion reactions. Transfusion. 2015 Aug;55(8):1838-46. doi: 10.1111/trf.13021. Epub 2015 Feb 23.
- Background: PubMed 29384784Semple JW, McVey MJ, Kim M, Rebetz J, Kuebler WM, Kapur R. Targeting Transfusion-Related Acute Lung Injury: The Journey From Basic Science to Novel Therapies. Crit Care Med. 2018 May;46(5):e452-e458. doi: 10.1097/CCM.0000000000002989.
- Background: PubMed 30281566Ducharme-Crevier L, Lacroix J. Interleukin-1 Receptor Antagonist and Interleukin-1beta: Risk Marker or Risk Factor for Pediatric Acute Respiratory Distress Syndrome? Pediatr Crit Care Med. 2018 Oct;19(10):993-995. doi: 10.1097/PCC.0000000000001713. No abstract available.
- Individual participant dataSharing planned: No. The summary of all relevant data
Related trials for Acute Lung Injury, Transfusion Related
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal A Omran, PHD study director
Professor of Biochemistry, Damanhour University.
Mohamed M Megahed, MD study director
Professor of Critical Care Medicine, Alexandria University.
Tamer N Zakhary, MD study chair
Ass. Professor of Critical Care Medicine, Alexandria University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid Injectable Product in people with Acute Lung Injury, Transfusion Related, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-8 (IL-8) (time frame: 96 hrs). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153487, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.