Role of ROTEM and Platelet Indices in Thrombocytopenic Patients .

NCT ID: NCT05850481

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-12-01

Brief Summary

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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. Examine the correlations between ROTEM parameters, platelet indices in thrombocytopenic patients .

Detailed Description

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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

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Patients With Low Platelets Counts

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with thrombocytopenia and normal coagulation results
* Patients with and without significant bleeding events

Exclusion Criteria

* 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 .
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Abd Elazeem Saber Selim

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Mohamed Helbawi, Lecturer

Role: STUDY_DIRECTOR

Clinical pathology department ,Assiut University Hospital

Mohammed Ashraf Mahmoud, Lecturer

Role: STUDY_DIRECTOR

Clinical pathology department ,Assiut University Hospital

Central Contacts

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Shaimaa Abdelazeem saber Selim, Assist Lecturer

Role: CONTACT

01006214247

Hanan Galal Abdel-Azeem, Professor

Role: CONTACT

01062226610

References

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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.

Reference Type BACKGROUND
PMID: 26787732 (View on PubMed)

Middelburg 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.

Reference Type BACKGROUND
PMID: 27159138 (View on PubMed)

Nguyen 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.

Reference Type BACKGROUND
PMID: 32446931 (View on PubMed)

Ni 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.

Reference Type BACKGROUND
PMID: 34876966 (View on PubMed)

Saqlain 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.

Reference Type BACKGROUND
PMID: 35634602 (View on PubMed)

Other Identifiers

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ROTEM in thrombocytopenia

Identifier Type: -

Identifier Source: org_study_id

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