Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)

Conditions

• Transplant Associated Microangiopathy TAM
• Transplant Complication

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

The goal of this observational study is to learn about the incidence of Transplant Associated Thrombotich Microangiopathy (TA-TMA), which is a known but underreported complication of Allogeneic Stem Cell Transplant (SCT). The main question it aims to answer is: What is the incidence of TA-TMA in adults undergoing SCT? How does TA-TMA diagnosis impact survival and other outcomes? Patients undergoing SCT will be eligible for this study, which will consist of collection of biological samples and standard clinical follow up.

Key Dates

Start date

Jul 1, 2026

Status verified

Mar 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

85 participants (estimated)

Arms

• Arm: Cohort 1
  Main Cohort of patients who fulfill Inclusion Criteria
• Arm: Cohort 2
  Patients who develop GVHD with any of the following characteristics and were not included in cohort 1 1. Grade III-IV aGVHD, or SR-aGVHD of any grade, whichever occurs first 2. Moderate to Severe cGVHD or SR-cGVHD of any grade, whichever occurs first
• Arm: Cohort 3
  Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive eculizumab

Primary Outcome Measure

Primary Objectives [ Time Frame: From enrollment until 1 year post SCT ]

Central Contacts

• Manuel R Espinoza Gutarra, M.D.
  205-975-2576
  [email protected]

Locations (1)

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