BleedingNCT03648190
Platelet Glycoproteins in Inherited Thrombocytopathy: Association With Aggregation Studies and Bleeding Severity
An observational study of Bleeding and Platelet Dysfunction, run by Assiut University at 1 site in Egypt.
Trial summary
Disorders of platelet function are characterized by variable mucocutaneous bleeding manifestations and excessive hemorrhage following surgical procedures or trauma. Generally, most patients have mild to moderate bleeding manifestations with a prolonged bleeding time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Platelet Dysfunction
- What is being tested?
- Flowcytometry analysis of platelets surface receptors
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 30 Aug 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Bleeding patients suffering from inherited qualitative platelets defect, with the exclusion of coagulation defects, acquired bleeding disorders and anti-platelet drugs intake. Both male and females are eligible with no age limits.
Who may be able to join
- Bleeding patients.
Who cannot join
- Coagulation defects, and those on anti-platelet drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 71515
Mohammed Ashraf, M.Sc, +201002867611, M1111a1111@yahoo.com
About this study
Official title: Evaluation of Platelet Surface Glycoproteins in Patients With Inherited Thrombocytopathy: Association With Aggregation Studies and Bleeding Severity
Disorders of platelet function are characterized by variable mucocutaneous bleeding manifestations and excessive hemorrhage following surgical procedures or trauma. Generally, most patients have mild to moderate bleeding manifestations with a prolonged bleeding time.
Platelet aggregation and secretion studies using platelet-rich plasma (PRP) provide evidence for platelet dysfunction but are neither predictive of severity of clinical manifestations nor the molecular mechanisms.
Read more
Glanzmann's thrombasthenia (GT) is a rare autosomal recessive genetic bleeding syndrome characterized by defects in platelet aggregometry. The clinical phenotype of patients with GT is variable. Some suffer from severe bleeding, while others have only mild bleeding. Some studies found bleeding severity in GT was influenced by the abundance and functioning of platelet receptors involved in aggregation and adhesion.
In addition to a complete medical history, a GT diagnosis requires a comprehensive laboratory workup, including platelet aggregation analysis, and a confirmation by flowcytometry or western blotting with monoclonal antibodies that recognize the GPIIb/IIIa complex.
Platelet flow cytometry is an emerging tool in diagnostic and therapeutic hematology. It is eminently suited to study the expression of platelet surface receptors both qualitatively as well as quantitatively.
Aim of the study:-
- Determine the role of flowcytometry as a quantitative measurement tool of platelets surface glycoproteins in patients with inherited thrombocytopathies and its correlation with bleeding severity of these patients.
- To compare the efficacy, advantages and disadvantages between platelets flowcytometry and aggregometer in diagnosing various inherited thrombocytopathies.
Read the detailed description
This study is a case-control observational study to be done at Clinical pathology department, Assiut University hospital, Assiut University, Egypt.
Patients with inherited qualitative platelets defect with clinical manifestations in the form of mucocutaneous bleeding or hemorrhage will be included in the study. Individuals with similar age and sex distribution to the patient group will act as controls. Control group shouldn't take medications or anti-platelet drugs for the preceding two weeks. They should have normal platelet count and morphology. Bleeding patients with acquired bleeding, coagulation defects, and those on anti-platelet drugs will be excluded from the study.
All Patients with inherited platelets function disorders will be subjected to:-
I - Careful history and clinical examination data collecting including:
Clinical history of bleeding such as (Sites, Severity and frequency of bleeding, trauma related events, history of surgical procedures, history of menorrhagia in females, history of packed red cell/ platelets transfusion.
II - Family history such as consanguinity, bleeding complications in any parents/ siblings.
III - Grading of bleeding severity: according to World Health Organization (WHO) bleeding assessment scale from grade 1 to grade 4.
The following routine investigations will be done:-
- Complete blood count (CBC) analysis.
- Prothrombin time, concentration and international normalized ratio (INR) assay.
- Activated partial thromboplastin time assay.
- Fibrinogen level and thrombin time assay.
The following specific investigations:-
- Platelets aggregation tests by aggregometer using four different agonists (ADP, Collagen, Arachidonic acid and ristocetin) on Bio/Data PAP-8E.
- Flowcytometry analysis of platelets receptors (CD 41, CD 61 and CD 42b) on BD FACSCalibur flowcytometry instrument.
Data collection and analysis will be done by computer program SPSS version 21 Chicago USA. Data expressed as mean ±SD, mean±SE, number and percentage. Using Manwhitny test to determine the significance for numeric variable and chisquare to determine the significance for non-parametric variable. ROC curve was done to determine the area under curve (AUC), sensitivity and specificity for each marker.
- Conditions
- Bleeding, Platelet Dysfunction
- Being tested
- Flowcytometry analysis of platelets surface receptors
- Keywords
- GT, CD
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowcytometry analysis of platelets surface receptorsDiagnostic test
Also called Platelets aggregation tests by aggregometer
BD FACSCalibur flowcytometry instrument.
Platelet flow cytometry is an emerging tool in diagnostic and therapeutic hematology. It is eminently suited to study the expression of platelet surface receptors both qualitatively as well as quantitatively.
Flow cytometry rapidly measures the specific characteristics of a large number of cells in suspension. Typically, the cells are labeled with fluorescently conjugated monoclonal antibodies (mAbs).
| Study group | Role | What they receive |
|---|---|---|
| Inherited qualitative platelets defect | Clinical manifestations in the form of mucocutaneous bleeding or hemorrhage.
Bleeding patients with acquired bleeding disorders, coagulation defects, and those on antiplatelet drugs will be excluded from the study. Receives: Diagnostic Test: Flowcytometry analysis of platelets surface receptors | |
| Control | Normal healthy participants, with no manifestations of bleeding disorders. Receives: Diagnostic Test: Flowcytometry analysis of platelets surface receptors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a protocol for Flowcytometry device to be used in routinely diagnosing cases with inherited platelets function defects.
Determine the ability of flowcytometry to assay (determine the levels of expression of each surface marker in percent) platelets surface glycoproteins (CD 41, CD 61 and CD 42b) using BD FACSCalibur flowcytometry instrument in patients with inherited thrombocytopathies and its correlation with bleeding severity of these patients with establishment of a protocol for it to be used in routinely diagnosing these cases.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies 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-control
- 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, Mohammed Ashraf, Assiut University
- Investigators
- Hanan Galal, MD, Principal investigator, Assiut UniversityMadleen Adel, MD, Study chair, Assiut UniversityEman Nasr-Eldin, MD, Study chair, Assiut UniversityMohammed Ashraf, M.Sc, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648190
- Sponsor's protocol ID
- 17200237
- Status last verified
- Aug 2018
- First submitted
- 21 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou L, Jiang M, Shen H, You T, Ding Z, Cui Q, Ma Z, Yang F, Xie Z, Shi H, Su J, Cao L, Lin J, Yin J, Dai L, Wang H, Wang Z, Yu Z, Ruan C, Xia L. Clinical and molecular insights into Glanzmann's thrombasthenia in China. Clin Genet. 2018 Aug;94(2):213-220. doi: 10.1111/cge.13366. Epub 2018 May 22.
PubMed 29675921Harrison P. Assessment of platelet function in the laboratory. Hamostaseologie. 2009 Jan;29(1):25-31.
PubMed 19151842Saboor M, Moinuddin M, Ilyas S. New horizons in platelets flow cytometry. Malays J Med Sci. 2013 Mar;20(2):62-6.
PubMed 23983579
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Surface Glycoproteins in Patients With Inherited Thrombocytopathy: Association With Aggregation Studies and Bleeding Severity
- ClinicalTrials.gov ID
- NCT03648190
- Acronym / sponsor ID
- 17200237
- Conditions
- Bleeding, Platelet Dysfunction
- Keywords
- GT, CD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 27 Aug 2018 (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.
Disorders of platelet function are characterized by variable mucocutaneous bleeding manifestations and excessive hemorrhage following surgical procedures or trauma. Generally, most patients have mild to moderate bleeding manifestations with a prolonged bleeding time.
Platelet aggregation and secretion studies using platelet-rich plasma (PRP) provide evidence for platelet dysfunction but are neither predictive of severity of clinical manifestations nor the molecular mechanisms.
Glanzmann's thrombasthenia (GT) is a rare autosomal recessive genetic bleeding syndrome characterized by defects in platelet aggregometry. The clinical phenotype of patients with GT is variable. Some suffer from severe bleeding, while others have only mild bleeding. Some studies found bleeding severity in GT was influenced by the abundance and functioning of platelet receptors involved in aggregation and adhesion.
In addition to a complete medical history, a GT diagnosis requires a comprehensive laboratory workup, including platelet aggregation analysis, and a confirmation by flowcytometry or western blotting with monoclonal antibodies that recognize the GPIIb/IIIa complex.
Platelet flow cytometry is an emerging tool in diagnostic and therapeutic hematology. It is eminently suited to study the expression of platelet surface receptors both qualitatively as well as quantitatively.
Aim of the study:-
- Determine the role of flowcytometry as a quantitative measurement tool of platelets surface glycoproteins in patients with inherited thrombocytopathies and its correlation with bleeding severity of these patients.
- To compare the efficacy, advantages and disadvantages between platelets flowcytometry and aggregometer in diagnosing various inherited thrombocytopathies.
Detailed description
This study is a case-control observational study to be done at Clinical pathology department, Assiut University hospital, Assiut University, Egypt.
Patients with inherited qualitative platelets defect with clinical manifestations in the form of mucocutaneous bleeding or hemorrhage will be included in the study. Individuals with similar age and sex distribution to the patient group will act as controls. Control group shouldn't take medications or anti-platelet drugs for the preceding two weeks. They should have normal platelet count and morphology. Bleeding patients with acquired bleeding, coagulation defects, and those on anti-platelet drugs will be excluded from the study.
All Patients with inherited platelets function disorders will be subjected to:-
I - Careful history and clinical examination data collecting including:
Clinical history of bleeding such as (Sites, Severity and frequency of bleeding, trauma related events, history of surgical procedures, history of menorrhagia in females, history of packed red cell/ platelets transfusion.
II - Family history such as consanguinity, bleeding complications in any parents/ siblings.
III - Grading of bleeding severity: according to World Health Organization (WHO) bleeding assessment scale from grade 1 to grade 4.
The following routine investigations will be done:-
- Complete blood count (CBC) analysis.
- Prothrombin time, concentration and international normalized ratio (INR) assay.
- Activated partial thromboplastin time assay.
- Fibrinogen level and thrombin time assay.
The following specific investigations:-
- Platelets aggregation tests by aggregometer using four different agonists (ADP, Collagen, Arachidonic acid and ristocetin) on Bio/Data PAP-8E.
- Flowcytometry analysis of platelets receptors (CD 41, CD 61 and CD 42b) on BD FACSCalibur flowcytometry instrument.
Data collection and analysis will be done by computer program SPSS version 21 Chicago USA. Data expressed as mean ±SD, mean±SE, number and percentage. Using Manwhitny test to determine the significance for numeric variable and chisquare to determine the significance for non-parametric variable. ROC curve was done to determine the area under curve (AUC), sensitivity and specificity for each marker.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inherited qualitative platelets defect | – | Diagnostic Test: Flowcytometry analysis of platelets surface receptorsClinical manifestations in the form of mucocutaneous bleeding or hemorrhage. Bleeding patients with acquired bleeding disorders, coagulation defects, and those on antiplatelet drugs will be excluded from the study. |
| Control | – | Diagnostic Test: Flowcytometry analysis of platelets surface receptorsNormal healthy participants, with no manifestations of bleeding disorders. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Bleeding patients suffering from inherited qualitative platelets defect, with the exclusion of coagulation defects, acquired bleeding disorders and anti-platelet drugs intake. Both male and females are eligible with no age limits.
Key inclusion criteria (1 listed)
- Bleeding patients.
Key exclusion criteria (1 listed)
- Coagulation defects, and those on anti-platelet drugs.
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 |
|---|---|---|
| Flowcytometry analysis of platelets surface receptorsAlso: Platelets aggregation tests by aggregometerBD FACSCalibur flowcytometry instrument. Platelet flow cytometry is an emerging tool in diagnostic and therapeutic hematology. It is eminently suited to study the expression of platelet surface receptors both qualitatively as well as quantitatively. Flow cytometry rapidly measures the specific characteristics of a large number of cells in suspension. Typically, the cells are labeled with fluorescently conjugated monoclonal antibodies (mAbs). | Diagnostic test | Control, Inherited qualitative platelets defect |
Primary outcome
Establishment of a protocol for Flowcytometry device to be used in routinely diagnosing cases with inherited platelets function defects.
Time frame: 6 Weeks
Determine the ability of flowcytometry to assay (determine the levels of expression of each surface marker in percent) platelets surface glycoproteins (CD 41, CD 61 and CD 42b) using BD FACSCalibur flowcytometry instrument in patients with inherited thrombocytopathies and its correlation with bleeding severity of these patients with establishment of a protocol for it to be used in routinely diagnosing these cases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 29675921Zhou L, Jiang M, Shen H, You T, Ding Z, Cui Q, Ma Z, Yang F, Xie Z, Shi H, Su J, Cao L, Lin J, Yin J, Dai L, Wang H, Wang Z, Yu Z, Ruan C, Xia L. Clinical and molecular insights into Glanzmann's thrombasthenia in China. Clin Genet. 2018 Aug;94(2):213-220. doi: 10.1111/cge.13366. Epub 2018 May 22.
- Background: PubMed 19151842Harrison P. Assessment of platelet function in the laboratory. Hamostaseologie. 2009 Jan;29(1):25-31.
- Background: PubMed 23983579Saboor M, Moinuddin M, Ilyas S. New horizons in platelets flow cytometry. Malays J Med Sci. 2013 Mar;20(2):62-6.
- Individual participant dataSharing planned: Undecided
Related trials for Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Hanan Galal, MD principal investigator
Assiut University
Madleen Adel, MD study chair
Assiut University
Eman Nasr-Eldin, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Platelet Dysfunction, run by Assiut 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 1 inclusion and 1 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 28 Aug 2018. 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. 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?
Contact Mohammed Ashraf, M.Sc (+201002867611, M1111a1111@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a protocol for Flowcytometry device to be used in routinely diagnosing cases with inherited platelets function defects. (time frame: 6 Weeks). 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 NCT03648190, which also lists 3 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 28 Aug 2018.