Role of ROTEM and Platelet Indices in Thrombocytopenic Patients .

April 29, 2023 updated by: Shaimaa Abd Elazeem Saber Selim, Assiut University

Role of Rotational Thromboelastometry and Platelet Indices as Predictors of Bleeding in Thrombocytopenic Patients.

  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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline
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
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measuring of Platelet distribution width (%)
Time Frame: 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
baseline
Measuring of Mean platelet volume (fL).
Time Frame: baseline
Interpretation the role of Platelet parameters (Mean platelet volume (fL)). and detection of their role in prediction of bleeding in these patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fatma Mohamed Helbawi, Lecturer, Clinical pathology department ,Assiut University Hospital
  • Study Director: Mohammed Ashraf Mahmoud, Lecturer, Clinical pathology department ,Assiut University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROTEM in thrombocytopenia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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