Platelet function and Treatment in patients with the blood desease Essential Thrombocytosis

Phase 1

• Conditions: Essential thrombocytosis; MedDRA version: 18.1Level: LLTClassification code 10015495Term: Essential thrombocytosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-002798-39-DK
• Lead Sponsor: Anne-Mette Hvas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age = 18
Patienter diagnosed with ET

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Current treatment with other antithrombotic drug than low dose aspirin
Patients at high risk of thrombosis, in whom aspirin can not be interrupted
Allergy or intolerance to aspirin
Pregnant or nursing
Women of childbearing potential who are sexually active and does not
using effective contraception
Inability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The project aims to examine why patients<br>with the disease essential<br>thrombocytosis (ET) are at increased risk of thrombosis, and then to examine if their treatment can be improved.<br>;Secondary Objective: not applicaple;Primary end point(s): The fraction of newly formed platelets in ET patients compared to<br>healthy individuals .<br>The difference between nadir value of serum thromboxane B<br>2 after ingestion of 75 mg of aspirin once a day for seven days as compared to the<br>ingestion of 37.5 mg aspirin twice daily in patients with ET.;Timepoint(s) of evaluation of this end point: End of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The fraction of immature platelets, count and mean volume of platelets<br> compared to healthy individuals.<br>Platelet count compared to platelet<br>aggregation in ET patients .<br>Platelet turnover compared to platelet aggregation in ET patients .<br>;Timepoint(s) of evaluation of this end point: end of trial