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RECRUITINGNCT07059026

Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients

Thrombotic Microangiopathy (TMA) Associated with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is a serious complication that is associated with increased morbidity, related to multiple or...

Lead sponsor: ITAC (Instituto de Trasplantes y Alta Complejidad)•1 locations•View source on ClinicalTrials.gov

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Contacts

Maria Belen Rosales Ostriz, MD

CONTACT

+54 9 11 5047-6401 belenrosalesostriz@gmail.com

Sponsors

Lead Sponsor

ITAC (Instituto de Trasplantes y Alta Complejidad)

This is a prospective multicenter non-interventional observational study that will include sites that perform routine screening using harmonized definitions and diagnostic criteria during the first 100 days post-HSCT (screening period). All patients entering the study (HSCT accessible population), regardless of suspicion or diagnosis of TMA, will be followed every 3 months up to 12 months after transplant to evaluate secondary outcomes (follow-up period).

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Adult patients (≥ 18 years) undergoing allogeneic HSCT in specialized centers that, as part of their usual follow-up protocol, carry out basic screening (laboratory/clinical) for TMA and in which patients consent (within the general transplant consent), to have their data used in observational studies.
•Patients with ≥ 3/laboratory/clinical diagnostic markers of TMA in two consecutive assessments within 14 days, namely: 1-Elevated Schistocytes in peripheral blood; 2-LDH above the upper normal limit; 3-De novo thrombocytopenia or requirement for platelet transfusion; 4-De novo anemia or requirement for red blood cell transfusion; 5-High blood pressure (≥140/90); 6-Protein/creatinine ratio \> 1mg/mg or proteinuria ≥ 30mg/dl in a random sample).
•Patients with suspected/diagnosed TMA who have signed the specific consent for the study.

Exclusion Criteria

•Participation in an interventional treatment study of any therapy for TMA.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 14, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment200

Start dateDec 2024

Last updatedJul 14, 2025

Condition

Thrombotic Microangiopathy

Locations shown

Instituto de Trasplantes de Alta Complejidad (ITAC)

Buenos Aires

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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