Thromboelastography, Platelet Function and Platelet Recovery in Haemato-oncologic Patients With Thrombocytopenia

Completed

• Conditions: Bone Marrow Diseases; Lymphoma

• Registration Number: NCT01928017
• Lead Sponsor: University of Bergen

Brief Summary

This is a prospective observational clinical study to characterise abnormalities of thromboelastography (TEG) parameters in patients with chemotherapy-induced thrombocytopenia. The investigators are also studying the relationship between Multiplate analysis and bleeding in these patients and the effect of platelet transfusions on thrombopoietin level and percent reticulated platelets.

The investigators' hypothesis is that changes in TEG-parameters reflect the patients tendency to bleed.

Detailed Description

Thrombocytopenic patients are followed with blood samples (thromboelastography, Multiplate, haematology) daily, Monday to Friday for up to 30 days.

In addition bleeding evaluation is done daily ,using a standardized questionnaire. The questionnaire is filled out after interview of the patient, and som times next of kin and nurses. Nurse journals and medical journals are also used to fill in the questionnaires.

For thromboelastography (TEG) we are looking at which parameters are abnormal, and if there is other factors than platelet count that influence the results. We will also compare TEG from days with and without bleeding, to see if they differ.

For Multiplate we are doing a pilot study to see whether this analysis can be of any use at all in this group of patients. We are looking into which factors that influence the Multiplate result, and if we can see a difference in the results if the patient is bleeding.

For reticulated platelets and thrombopoietin we are studying the levels related to platelet transfusions.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Patients are eligible for this study if:

They have a haemato-oncologic disease They have, or are expected to have, thrombocytopenia They are expected to need at least one platelet transfusion They are aged 18 years or over They consent to participate

Exclusion Criteria

Patients are not eligible for this study if:

They have a known congenital clotting disorder They need anticoagulants regularly in the study period They have immune thrombocytopenic purpura

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MA	1 year	To characterise changes in the TEG-parameter MA in patients with chemotherapy-induced thrombocytopenia

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway