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NCT Number: NCT01648556

Research of Predictive Factors to Immune Thrombopenic Purpura

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood tests and bone marrow biopsy repeated

Other

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.

Other names: The test in corticoids by the prednisone per os

Primary outcomes

  1. the result of cytogenetics medullary

    Time frame: two years after inclusion

    the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.

Secondary outcomes

  1. dosage of the TPO

    Time frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion)

  2. the result to the antibodies antiplatelet (positive or negative) for MAIPA

    Time frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)

  3. The isotopic lifetime of platelet

    Time frame: EVERY 4 MONTHS (followed every four months during two years apres inclusion)

    < or > 3.5 days

  4. The test in corticoids by the prednisone per os

    Time frame: EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Abbeville Hospital Center
  • Assistance Publique Hopitaux De Marseille
  • CHRU BREST
  • CHRU LILLE
  • Centre Hospitalier Intercommunal de Compiègne-Noyon
  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire de Nice
  • GROUPE HOSPITALIER INSTITUT CATHOLIQUE
  • Henri Mondor University Hospital
  • Hôpital Jean Verdier
  • Rennes University Hospital
  • University Hospital, Angers
  • University Hospital, Caen
  • University Hospital, Toulouse

Registry information

Official study title

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

Acronym: PREDI-PTI

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2012
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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