Patients With Low Platelets CountsNCT05850481
Role of ROTEM and Platelet Indices in Thrombocytopenic Patients .
An observational study of Patients With Low Platelets Counts, run by Assiut University.
Trial summary
1. Investigate the role of thromboelastometry (ROTEM) parameters in the prediction of bleeding events in thrombocytopenic patients. 2. Interpretation of platelet indices in thrombocytopenic patients and detection of their role in prediction of bleeding in these patients . 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Low Platelets Counts
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Dec 2024
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Patients diagnosed as hypoproliferative thrombocytopenias(aplastic anaemia, acute leukaemia) and destructive thrombocytopenias (Idiopathic thrombocytopenia, secondry) with platelet count < 50 x 103 / μL and normal coagulation results * Patients with and without significant bleeding events
Who may be able to join
- Patients with thrombocytopenia and normal coagulation results
- Patients with and without significant bleeding events
Who cannot join
- patients with abnormal routine coagulation results (M3,liver diseases,........)
- patients who had received blood transfusions in the last 5 days.
- patients taking anticoagulant drugs or antiplatelet drugs .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Rotational Thromboelastometry and Platelet Indices as Predictors of Bleeding in Thrombocytopenic Patients.
- Investigate the role of thromboelastometry (ROTEM) parameters in the prediction of bleeding events in thrombocytopenic patients.
- Interpretation of platelet indices in thrombocytopenic patients and detection of their role in prediction of bleeding in these patients .
- Examine the correlations between ROTEM parameters, platelet indices in thrombocytopenic patients .
Read the detailed description
Platelets are anucleate cells derived from megakaryocytes that play an important role in maintaining the integrity of the vascular endothelium and preventing haemorrhage. Adult platelet counts range from 150 - 450x10^3 / μL.The presence of a subnormal amount of platelets(<150 x 10^3 / μL)in circulating blood is referred to as thrombocytopenia, It is one of the most common haematological disorders and can become lifethreatening in case of severe disease. It could be due to a lack of platelet production or the degradation of platelets in the periphery. Hypoproliferative thrombocytopenias (aplastic anaemia, acute leukaemia) are one type of thrombocytopenia, while destructive thrombocytopenias (Idiopathic thrombocytopenia, secondry to SLE) are another. Bleeding is more likely in patients with severe thrombocytopenia.various reports have shown that platelet count is not a reliable predictor of clinically significant hemorrhage in thrombocytopenic patients Therefore, it may not be appropriate to use platelet count to guide treatment. Unfortunately, platelet function assays are often not sufficiently sensitive when platelet count is very low. As such, there remains the need to identify a predictor or set of parameters that can accurately assess the risk of hemorrhage in this patients.
The interpretation of platelet indices can aid in the initial care of thrombocytopenic patients ,Given the convenience and non-invasive nature of platelet indices calculation Although there are few studies in the literature on the significance of various platelet indices. the current study will be conducted to underline their importance in the diagnosis of thrombocytopenia.
Thromboelastography is a global coagulation test . The test is used to assess the change in elasticity over time of whole blood samples . Thromboelastography provides information about platelet function, coagulation, and fibrinolysis in just one assay monitoring.After improvement and automation, a thromboelastographic system known as ROTEM (rotational thromboelastometry) is now widely used in various clinical settings to determin the cause of bleeding in patients, evaluate bleeding risk, monitor the effect of anticoagulant drugs.and guide treatment.
The International Society on Thrombosis and Hemostasis (ISTH) is one of the well-known tools for bleeding assessment . The ISTH-BAT is a diagnostic questionnaire to screen patient depending on presence and absence of bleeding and also their severity.
- Conditions
- Patients With Low Platelets Counts
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the role of EXTEM in detection of bleeding risk in thrombocytopenic patients by using thromboelastometry (ROTEM) delta analyzer
ROTEM assays will be performed using a ROTEM delta analyzer. Parameters such as EXTEM A10, EXTEM MCF, and EXTEM AUC will be obtained from EXTEM assay. This measurements will be used to predict risk of bleeding in patients with low platelet count
Measured: baseline
investigate the role of FIBTEM ROTEM parameter in detection of bleeding risk in thrombocytopenic patients by using thromboelastometry (ROTEM) delta analyzer
FIBTEM ROTEM parameter will be performed using a ROTEM delta analyzer Platelet MCE will be calculated by subtracting FIBTEM MCE from EXTEM MCE (Platelet MCE = EXTEM MCE - FibTEM MCE).This measurements will be used to predict risk of bleeding in patients with low platelet count
Measured: baseline
Secondary outcomes (2)
Measuring of Platelet distribution width (%)
Interpretation the role of Platelet parameter (Platelet distribution width (%) )and detection of their role in prediction of bleeding in patients with low platelet count
Measured: baseline
Measuring of Mean platelet volume (fL).
Interpretation the role of Platelet parameters (Mean platelet volume (fL)). and detection of their role in prediction of bleeding in these patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patients With Low Platelets CountsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Abd Elazeem Saber Selim, Assiut University
- Investigators
- Fatma Mohamed Helbawi, Lecturer, Study director, Clinical pathology department ,Assiut University HospitalMohammed Ashraf Mahmoud, Lecturer, Study director, Clinical pathology department ,Assiut University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850481
- Sponsor's protocol ID
- ROTEM in thrombocytopenia
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parise LV. Introduction to a review series: megakaryocytes to platelets in health and disease. Blood. 2016 Mar 10;127(10):1215. doi: 10.1182/blood-2015-11-664029. Epub 2016 Jan 19. No abstract available.
PubMed 26787732Middelburg RA, Carbaat-Ham JC, Hesam H, Ragusi MA, Zwaginga JJ. Platelet function in adult ITP patients can be either increased or decreased, compared to healthy controls, and is associated with bleeding risk. Hematology. 2016 Oct;21(9):549-51. doi: 10.1080/10245332.2016.1180097. Epub 2016 May 9.
PubMed 27159138Nguyen TH, Tran TT, Hoang TT, Nguyen TT. Rotational thromboelastometry parameters as predicting factors for bleeding in immune thrombocytopenic purpura. Hematol Oncol Stem Cell Ther. 2021 Mar;14(1):27-32. doi: 10.1016/j.hemonc.2020.05.003. Epub 2020 May 15.
PubMed 32446931Ni L, Xue P, An C, Yu X, Qu J, Yao Y, Li Y. Establishment of Normal Range for Thromboelastography in Healthy Middle-Aged and Elderly People of Weihai in China. J Healthc Eng. 2021 Nov 28;2021:7119779. doi: 10.1155/2021/7119779. eCollection 2021.
PubMed 34876966Saqlain N, Fateen T, Tufail H, Mazher N. Utility of the ISTH bleeding assessment tool (BAT) in diagnosis of Glanzmann Thrombasthenia patients. Pak J Med Sci. 2022 Mar-Apr;38(4Part-II):791-795. doi: 10.12669/pjms.38.4.5361.
PubMed 35634602
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Rotational Thromboelastometry and Platelet Indices as Predictors of Bleeding in Thrombocytopenic Patients.
- ClinicalTrials.gov ID
- NCT05850481
- Acronym / sponsor ID
- ROTEM in thrombocytopenia
- Conditions
- Patients With Low Platelets Counts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 May 2023 (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.
- Investigate the role of thromboelastometry (ROTEM) parameters in the prediction of bleeding events in thrombocytopenic patients.
- Interpretation of platelet indices in thrombocytopenic patients and detection of their role in prediction of bleeding in these patients .
- Examine the correlations between ROTEM parameters, platelet indices in thrombocytopenic patients .
Detailed description
Platelets are anucleate cells derived from megakaryocytes that play an important role in maintaining the integrity of the vascular endothelium and preventing haemorrhage. Adult platelet counts range from 150 - 450x10^3 / μL.The presence of a subnormal amount of platelets(<150 x 10^3 / μL)in circulating blood is referred to as thrombocytopenia, It is one of the most common haematological disorders and can become lifethreatening in case of severe disease. It could be due to a lack of platelet production or the degradation of platelets in the periphery. Hypoproliferative thrombocytopenias (aplastic anaemia, acute leukaemia) are one type of thrombocytopenia, while destructive thrombocytopenias (Idiopathic thrombocytopenia, secondry to SLE) are another. Bleeding is more likely in patients with severe thrombocytopenia.various reports have shown that platelet count is not a reliable predictor of clinically significant hemorrhage in thrombocytopenic patients Therefore, it may not be appropriate to use platelet count to guide treatment. Unfortunately, platelet function assays are often not sufficiently sensitive when platelet count is very low. As such, there remains the need to identify a predictor or set of parameters that can accurately assess the risk of hemorrhage in this patients.
The interpretation of platelet indices can aid in the initial care of thrombocytopenic patients ,Given the convenience and non-invasive nature of platelet indices calculation Although there are few studies in the literature on the significance of various platelet indices. the current study will be conducted to underline their importance in the diagnosis of thrombocytopenia.
Thromboelastography is a global coagulation test . The test is used to assess the change in elasticity over time of whole blood samples . Thromboelastography provides information about platelet function, coagulation, and fibrinolysis in just one assay monitoring.After improvement and automation, a thromboelastographic system known as ROTEM (rotational thromboelastometry) is now widely used in various clinical settings to determin the cause of bleeding in patients, evaluate bleeding risk, monitor the effect of anticoagulant drugs.and guide treatment.
The International Society on Thrombosis and Hemostasis (ISTH) is one of the well-known tools for bleeding assessment . The ISTH-BAT is a diagnostic questionnaire to screen patient depending on presence and absence of bleeding and also their severity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients diagnosed as hypoproliferative thrombocytopenias(aplastic anaemia, acute leukaemia) and destructive thrombocytopenias (Idiopathic thrombocytopenia, secondry) with platelet count < 50 x 103 / μL and normal coagulation results * Patients with and without significant bleeding events
Key inclusion criteria (2 listed)
- Patients with thrombocytopenia and normal coagulation results
- Patients with and without significant bleeding events
Key exclusion criteria (3 listed)
- patients with abnormal routine coagulation results (M3,liver diseases,........)
- patients who had received blood transfusions in the last 5 days.
- patients taking anticoagulant drugs or antiplatelet drugs .
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
investigate the role of EXTEM in detection of bleeding risk in thrombocytopenic patients by using thromboelastometry (ROTEM) delta analyzer
Time frame: baseline
ROTEM assays will be performed using a ROTEM delta analyzer. Parameters such as EXTEM A10, EXTEM MCF, and EXTEM AUC will be obtained from EXTEM assay. This measurements will be used to predict risk of bleeding in patients with low platelet count
investigate the role of FIBTEM ROTEM parameter in detection of bleeding risk in thrombocytopenic patients by using thromboelastometry (ROTEM) delta analyzer
Time frame: baseline
FIBTEM ROTEM parameter will be performed using a ROTEM delta analyzer Platelet MCE will be calculated by subtracting FIBTEM MCE from EXTEM MCE (Platelet MCE = EXTEM MCE - FibTEM MCE).This measurements will be used to predict risk of bleeding in patients with low platelet count
2 secondary outcomes
Measuring of Platelet distribution width (%)
Time frame: baseline
Measuring of Mean platelet volume (fL).
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 26787732Parise LV. Introduction to a review series: megakaryocytes to platelets in health and disease. Blood. 2016 Mar 10;127(10):1215. doi: 10.1182/blood-2015-11-664029. Epub 2016 Jan 19. No abstract available.
- Background: PubMed 27159138Middelburg RA, Carbaat-Ham JC, Hesam H, Ragusi MA, Zwaginga JJ. Platelet function in adult ITP patients can be either increased or decreased, compared to healthy controls, and is associated with bleeding risk. Hematology. 2016 Oct;21(9):549-51. doi: 10.1080/10245332.2016.1180097. Epub 2016 May 9.
- Background: PubMed 32446931Nguyen TH, Tran TT, Hoang TT, Nguyen TT. Rotational thromboelastometry parameters as predicting factors for bleeding in immune thrombocytopenic purpura. Hematol Oncol Stem Cell Ther. 2021 Mar;14(1):27-32. doi: 10.1016/j.hemonc.2020.05.003. Epub 2020 May 15.
- Background: PubMed 34876966Ni L, Xue P, An C, Yu X, Qu J, Yao Y, Li Y. Establishment of Normal Range for Thromboelastography in Healthy Middle-Aged and Elderly People of Weihai in China. J Healthc Eng. 2021 Nov 28;2021:7119779. doi: 10.1155/2021/7119779. eCollection 2021.
- Background: PubMed 35634602Saqlain N, Fateen T, Tufail H, Mazher N. Utility of the ISTH bleeding assessment tool (BAT) in diagnosis of Glanzmann Thrombasthenia patients. Pak J Med Sci. 2022 Mar-Apr;38(4Part-II):791-795. doi: 10.12669/pjms.38.4.5361.
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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.
Fatma Mohamed Helbawi, Lecturer study director
Clinical pathology department ,Assiut University Hospital
Mohammed Ashraf Mahmoud, Lecturer study director
Clinical pathology department ,Assiut University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Low Platelets Counts, 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 3 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 9 May 2023. 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?
Contact Shaimaa Abdelazeem saber Selim, Assist Lecturer (01006214247, Shaimaaselim95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the role of EXTEM in detection of bleeding risk in thrombocytopenic patients by using thromboelastometry (ROTEM) delta analyzer (time frame: baseline). The study lists 2 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 NCT05850481, which also lists 5 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 9 May 2023.