Research of Predictive Factors to Immune Thrombopenic Purpura

Purpura Thrombopenic Clinical Trial

— PREDI-PTI  

Official title:

Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01648556
• Other study ID #: PI2011_843_0002
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2012
• Last updated: August 1, 2016
• Start date: September 2012
• Est. completion date: September 2018

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: JEAN PIERRE MAROLLEAU
• Phone: 00 33 33 45 59 14
• Email: marolleau.jean-pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Health authority: France : ANSM French health product safety Agency
• Study type: Interventional

Clinical Trial Summary

It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.

Description:

It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.

The principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of PTI in front of a thrombopenia isolated in elderly.

The secondary endpoints are :

• to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of PTI or SMD

• to study the respective frequency of the PTI and the SMD in front of a thrombopenia seemingly isolated of the subject of more than 60 years.

200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.They will be followed every 4 months, during two years.

In every visit, will be realized a clinical examination, a blood film, a haemogram.

If the haemogram is abnormal, a bone marrow biopsy is realized. The patient who presents a myelodysplastic syndrome is excluded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Rate of platelet < 100 G/l for less than 12 months ,

• age = ou > 60 years,

• haemoglobin > ou = 12 g / dl at the woman, > ou = 13 g/dl at the man,

• polymorphonuclear neutrophil > ou = 1.7 G/l,

• monocytes < ou= 1 G/l,

• lymphocytes < ou = à 4 G/l,

• VGM < 100 fL, blood film normal,

• informed consent,

• expectation of life > 6 months

Exclusion Criteria:

• hepatomegaly,

• splenomegaly,

• hepatic abnormality,

• blood coagulation abnormality,

• antecedent of auto-immune disease,

• drug thrombopenia,

• HIV, VHB or VHC positive,

• antecedent of malicious tumor in the 5 years before inclusion

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Purpura
• Purpura Thrombopenic
• Purpura, Thrombocytopenic

Intervention

Other:
• Blood tests and bone marrow biopsy repeated
Blood tests are realized for the dosage of the TPO, the dosage of the antiplatelet antibodies, to measure isotopic lifetime of platelet. The test in corticoids by the prednisone per os is realized too. The bone marrow biopsy is realized at the inclusion and during follow-ups if the haemogram is abnormal.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the result of cytogenetics medullary	the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.	two years after inclusion	No
Secondary	dosage of the TPO		EVERY 4 MONTHS (followed every four months during two years apres inclusion)	No
Secondary	the result to the antibodies antiplatelet (positive or negative) for MAIPA		EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)	No
Secondary	The isotopic lifetime of platelet	< or > 3.5 days	EVERY 4 MONTHS (followed every four months during two years apres inclusion)	No
Secondary	The test in corticoids by the prednisone per os	1 mg / kg / day for 3 weeks The therapeutic test is considered as positive if a number of platelets is > 50 G/l with at least a doubling of the platelet rate before treatment	EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)	No