Prospective Study of Thrombotic Microangiopathy (TMA) Associated With Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) In Adult Patients From Argentina

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Thrombotic Microangiopathy (TMA) Associated with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is a serious complication that is associated with increased morbidity, related to multiple organ failure, with increased mortality in transplant patients. The incidence and evolution of TMA, especially in the adult population, is unclear due to the lack of early systematic screening and clear criteria for its diagnosis. For this reason, we designed this protocol to study the incidence and evolution of TMA Associated with allogeneic HSCT in adult patients from Argentina.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Argentina
Instituto de Trasplantes de Alta Complejidad (ITAC)
RECRUITING
Buenos Aires
Contact Information
Primary
Maria Belen Rosales Ostriz, MD
belenrosalesostriz@gmail.com
+54 9 11 5047-6401
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
HSCT
Adults with Allogeneic Hematopoietic Stem Cell Transplantation
Sponsors
Leads: ITAC (Instituto de Trasplantes y Alta Complejidad)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials