Platelet Changes in Cases of Iron OverloadNCT04329286
Platelet Changes in Cases of Chronic Iron Over Load
An observational study of Platelet Changes in Cases of Iron Overload, run by Assiut University.
Trial summary
Iron demand: The average daily demand to fit the cell biological metabolism is balanced between intake and lost which about 1-2 mg. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Platelet Changes in Cases of Iron Overload
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 May 2022
- Phase
- Observational
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Platelet Changes in Cases of Iron Overload(IO)
Who may be able to join
- Patients around age of 6 to 18 years
- Patients with thalassemia disease
Who cannot join
- - Patients less than 6 years and more than 18 years.
- Patients with sever inflammatory disease.
- Patients with any malignant disease.
- Patients take steroid or bone marrow suppression drugs.
- Patients with aplastic anemia or pancytopenia.
About this study
Iron demand: The average daily demand to fit the cell biological metabolism is balanced between intake and lost which about 1-2 mg.
Read the detailed description
Iron demand: The average daily demand to fit the cell biological metabolism is balanced between intake and lost which about 1-2 mg. One unit of packed red blood cells contains approximately 200-250 mg of iron.Thus, patients who arereceiving an average of 2 to 4 units of blood monthly willhave an iron intake of 5000to 10 000 mg of iron per year. Iron overload(IO) A condition in which the body takes up and stores more iron than it needs from any cause. Iron overload constitutes a major problem in patients receivingregular blood transfusion. Patients with β-thalassemia,sickle cell anemia, and congenital and refractory anemiasonchronic transfusion programs accumulate iron in variousbody organs. Untreated iron overload will eventually lead todamage of the liver, endocrine organs, and most seriously theheart(1).Acquired platelet function defect might be one of thecomplications of iron overload. This could occur indirectlythrough the effect of iron load on the liver and other organsor might occur due to effect of iron load on platelet functiondirectly. Dleteriouscomlications contributed by chemical reactive deregulated iron may affect cellular homeostasis systematically lead to tissue and organ damage when this toxicity occurred in blood cells ,alteration of peripheral hematological profile concerning erythrocyte,leucocyte and Platelet. On the other hand, acquired platelet function defects are classified broadly into defects that are intrinsic or extrinsic to the platelets. Acquired platelets defect are due to medications, medical conditions, underlying hematologic diseases, and are more frequent than inherited causes of platelets defects. (2) Platelet function is also influenced by changes in membranefluidity that has an important role in the expressionof platelet receptors and in modulating the activity ofproteins like phospholipase C or proteinkinase C(3). Ithas been shown (4) that changes in membrane fluidityare associated to altered aggregation/agglutination functionof freshly prepared platelets. The platelet aggregationresponse is modified by monovalent cations (whichalter fibrinogen binding) and monovalent anions thatenhance hydroxyl radicals production of platelets inducing platelet activation (5) Reactive oxygen species(ROS) are involved in integrin aIIbb3 activation(6,7). Moreover, bursts of ROS are generated in platelets exposed to thrombin (8). We herein report the case of a patient with acquired plateletfunction defect associated with iron overload as a consequenceof chronic blood transfusion. Therefore, we emphasizethe necessity of further studies to confirm directcorrelation between iron overload as a causative agent andplatelets dysfunction. And we recommend screening forplatelet function in patients receiving chronic blood transfusionaiming at possible prevention of any lifethreateningbleeding.
One of the most commonly used laboratorymarkers to early characterize platelet functionis the mean platelet volume (MPV). Increasedplatelet volume mayindicate its greater content ingranules, showing a platelet activation also betteraggregation and more reactive than the ordinarysize one. Limited study and the inconsistent resultare available regarding the platelet function studyin IO complicated condition. Higher MPV wasidentified in heterozygous beta-thalassemiapatientswith no correlation with cardiovascularrelatedrisks( 9). However, but in line with this study, adefect in platelet aggregation indicated by ahyporeactivityof platelet after induction withADP, ristocetin, and collagen was showed in majorthalassemia children patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Changes in Cases of Iron Overload(IO)
Platelet Changes in Cases of Iron Overload(IO)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet Changes in Cases of Iron OverloadStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakleen Merzek Lowiz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329286
- Sponsor's protocol ID
- Platelet changes
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood. 2012 Nov 1;120(18):3657-69. doi: 10.1182/blood-2012-05-370098. Epub 2012 Aug 23.
PubMed 22919029Vlasic N, Medow MS, Schwarz SM, Pritchard KA Jr, Stemerman MB. Lipid fluidity modulates platelet aggregation and agglutination in vitro. Life Sci. 1993;53(13):1053-60. doi: 10.1016/0024-3205(93)90258-5.
PubMed 8366768Wachowicz B, Olas B, Zbikowska HM, Buczynski A. Generation of reactive oxygen species in blood platelets. Platelets. 2002 May;13(3):175-82. doi: 10.1080/09533710022149395.
PubMed 12180500Cikrikcioglu MA, Celik K, Ekinci I, Nasifov M, Toprak AE, Cetin G, Genc S. Mean Platelet Volume in Heterozygous Beta Thalassaemia. Acta Haematol. 2017;137(2):100-105. doi: 10.1159/000455813. Epub 2017 Feb 17.
PubMed 28208125
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Changes in Cases of Chronic Iron Over Load
- ClinicalTrials.gov ID
- NCT04329286
- Acronym / sponsor ID
- Platelet changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 1 Apr 2020 (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.
Iron demand: The average daily demand to fit the cell biological metabolism is balanced between intake and lost which about 1-2 mg.
Detailed description
Iron demand: The average daily demand to fit the cell biological metabolism is balanced between intake and lost which about 1-2 mg. One unit of packed red blood cells contains approximately 200-250 mg of iron.Thus, patients who arereceiving an average of 2 to 4 units of blood monthly willhave an iron intake of 5000to 10 000 mg of iron per year. Iron overload(IO) A condition in which the body takes up and stores more iron than it needs from any cause. Iron overload constitutes a major problem in patients receivingregular blood transfusion. Patients with β-thalassemia,sickle cell anemia, and congenital and refractory anemiasonchronic transfusion programs accumulate iron in variousbody organs. Untreated iron overload will eventually lead todamage of the liver, endocrine organs, and most seriously theheart(1).Acquired platelet function defect might be one of thecomplications of iron overload. This could occur indirectlythrough the effect of iron load on the liver and other organsor might occur due to effect of iron load on platelet functiondirectly. Dleteriouscomlications contributed by chemical reactive deregulated iron may affect cellular homeostasis systematically lead to tissue and organ damage when this toxicity occurred in blood cells ,alteration of peripheral hematological profile concerning erythrocyte,leucocyte and Platelet. On the other hand, acquired platelet function defects are classified broadly into defects that are intrinsic or extrinsic to the platelets. Acquired platelets defect are due to medications, medical conditions, underlying hematologic diseases, and are more frequent than inherited causes of platelets defects. (2) Platelet function is also influenced by changes in membranefluidity that has an important role in the expressionof platelet receptors and in modulating the activity ofproteins like phospholipase C or proteinkinase C(3). Ithas been shown (4) that changes in membrane fluidityare associated to altered aggregation/agglutination functionof freshly prepared platelets. The platelet aggregationresponse is modified by monovalent cations (whichalter fibrinogen binding) and monovalent anions thatenhance hydroxyl radicals production of platelets inducing platelet activation (5) Reactive oxygen species(ROS) are involved in integrin aIIbb3 activation(6,7). Moreover, bursts of ROS are generated in platelets exposed to thrombin (8). We herein report the case of a patient with acquired plateletfunction defect associated with iron overload as a consequenceof chronic blood transfusion. Therefore, we emphasizethe necessity of further studies to confirm directcorrelation between iron overload as a causative agent andplatelets dysfunction. And we recommend screening forplatelet function in patients receiving chronic blood transfusionaiming at possible prevention of any lifethreateningbleeding.
One of the most commonly used laboratorymarkers to early characterize platelet functionis the mean platelet volume (MPV). Increasedplatelet volume mayindicate its greater content ingranules, showing a platelet activation also betteraggregation and more reactive than the ordinarysize one. Limited study and the inconsistent resultare available regarding the platelet function studyin IO complicated condition. Higher MPV wasidentified in heterozygous beta-thalassemiapatientswith no correlation with cardiovascularrelatedrisks( 9). However, but in line with this study, adefect in platelet aggregation indicated by ahyporeactivityof platelet after induction withADP, ristocetin, and collagen was showed in majorthalassemia children patients
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Platelet Changes in Cases of Iron Overload(IO)
Key inclusion criteria (2 listed)
- Patients around age of 6 to 18 years
- Patients with thalassemia disease
Key exclusion criteria (5 listed)
- - Patients less than 6 years and more than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet Changes in Cases of Iron Overload(IO)
Time frame: 1year
Platelet Changes in Cases of Iron Overload(IO)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Background: PubMed 22919029Hoffbrand AV, Taher A, Cappellini MD. How I treat transfusional iron overload. Blood. 2012 Nov 1;120(18):3657-69. doi: 10.1182/blood-2012-05-370098. Epub 2012 Aug 23.
- Background: PubMed 8366768Vlasic N, Medow MS, Schwarz SM, Pritchard KA Jr, Stemerman MB. Lipid fluidity modulates platelet aggregation and agglutination in vitro. Life Sci. 1993;53(13):1053-60. doi: 10.1016/0024-3205(93)90258-5.
- Background: PubMed 12180500Wachowicz B, Olas B, Zbikowska HM, Buczynski A. Generation of reactive oxygen species in blood platelets. Platelets. 2002 May;13(3):175-82. doi: 10.1080/09533710022149395.
- Background: PubMed 28208125Cikrikcioglu MA, Celik K, Ekinci I, Nasifov M, Toprak AE, Cetin G, Genc S. Mean Platelet Volume in Heterozygous Beta Thalassaemia. Acta Haematol. 2017;137(2):100-105. doi: 10.1159/000455813. Epub 2017 Feb 17.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Changes in Cases of Iron Overload, run by Assiut University.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Platelet Changes in Cases of Iron Overload(IO) (time frame: 1year). 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 NCT04329286, which also lists 4 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 1 Apr 2020.