Role of ROTEM and Platelet Indices in Thrombocytopenic Patients .
- Conditions
- Patients With Low Platelets Counts
- Registration Number
- NCT05850481
- Lead Sponsor
- Assiut University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Patients with thrombocytopenia and normal coagulation results
- Patients with and without significant bleeding events
- 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 .
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method investigate the role of EXTEM in detection of bleeding risk in thrombocytopenic patients by using thromboelastometry (ROTEM) delta analyzer 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 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
- Secondary Outcome Measures
Name Time Method Measuring of Platelet distribution width (%) baseline Interpretation the role of Platelet parameter (Platelet distribution width (%) )and detection of their role in prediction of bleeding in patients with low platelet count
Measuring of Mean platelet volume (fL). baseline Interpretation the role of Platelet parameters (Mean platelet volume (fL)). and detection of their role in prediction of bleeding in these patients