Q29 – 39: Thrombotic Microangiopathy (TMA)

!Thrombotic Microangiopathy (TMA)
Thrombotic Microangiopathy (TMA) questions can only be completed on the 100-day and 6-month follow-up forms. These questions will be disabled for all subsequent reporting periods.

The purpose of this section is to capture any impairments or disorders present during the current reporting period, regardless of treatment or intervention, unless otherwise specified. Review each impairment or disorder description to determine whether treatment or intervention is required for reporting the condition.

*Reporting Multiple Thrombotic Microangiopathies
Complete Was post-infusion thrombotic microangiopathy (TMA) or similar syndrome present through Date TMA resolved questions to report multiple thrombotic microangiopathies by adding an additional instance in the FormsNet3^SM application.

Questions 29 – 30: Was post-infusion thrombotic microangiopathy (TMA) or similar syndrome present? includes microangiopathy, thrombotic purpura (TTP), hemolytic uremic syndrome (HUS)

Thrombotic microangiopathy (TMA) is a multifactorial condition where intravascular platelet activation, formation of thrombi, and microangiopathic hemolytic anemia occur due to generalized endothelial dysfunction. Organ injury, specifically the kidney, may occur as a result of these processes.¹ Characteristics of thrombotic microangiopathy includes microangiopathic hemolysis, thrombocytopenia (< 50 ×10⁹/L), neurological changes, and pulmonary dysfunction. Other laboratory features include:

• LDH greater than the center-specific upper limit of normal
• Serum creatinine > 2 mg/dL or >50% rise over baseline
• Bilirubin is greater than twice the center-specific upper limit of normal

¹ Jodele, S., M. Davies, and B.L. Laskin. “Diagnostic and Risk Criteria for HSCT-associated Thrombotic Microangiopathy: A Study in Children and Young Adults.” Blood 124.4 (2014): 645-53. Web.

Similar syndromes include:

• Microangiopathy: Disease of the capillaries where the capillaries bleed and slow the flow of blood due to thickening and weakening of capillary walls.
• Thrombotic purpura (TTP): Blood disorder where blood clots form in the small blood vessels of the body.
• Hemolytic uremic syndrome (HUS): Abnormal destruction of red blood cells which block the kidneys resulting in kidney failure. May be caused by Escherichia coli, other infections, and medications.

Indicate if TMA or a similar syndrome, such as microangiopathy, thrombotic purpura (TTP), and hemolytic uremic syndrome (HUS), was present in the current reporting period.

Report Developed in the following scenarios:

• This is the first time the recipient was diagnosed with TMA or a similar syndrome in the reporting period.
• TMA or a similar syndrome resolved in a prior reporting period and then recurred in the current reporting period.

If TMA or a similar syndrome Developed, report the onset date. If the diagnosis was determined at an outside center and no documentation of a clinical, pathological, or laboratory assessment is available, the dictated date of diagnosis within a physician note may be reported.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Report Persisted in the following scenarios:

• TMA or a similar syndrome was diagnosed pre-infusion and persisted into the Day 100 reporting period.
• TMA or a similar syndrome was diagnosed (or persisted) in the prior reporting period and persisted into the current reporting period.

If TMA or a similar syndrome was not present in the current reporting period or unknown if present, select Not present.

Question 31: Specify signs and symptoms (check all that apply)

Report all TMA or a similar syndrome signs and symptoms at diagnosis or recurrence, if applicable.

Questions 32 – 35: Was TMA evaluated by biopsy?

Specify if biopsy was completed at diagnosis or recurrence, if applicable of TMA or a similar syndrome. If Yes, specify the results.

If a biopsy was not completed or unknown, select No.

Questions 36 – 37: Specify therapy given for TMA (check all that apply)

Report therapy given in the reporting period for TMA or a similar syndrome. Select all that apply.

If Other therapy is selected, specify the treatment.

If therapy was not given, select None.

Questions 38 – 39: Did TMA resolved? (normalization of renal function, LDH, and resolution or improvement in renal and / or neurologic dysfunction)

Indicate if TMA or a similar syndrome resolved during the reporting period. If Yes, report the first date when the following criteria was met:

• Renal function normalized by institutional guidelines
• LDH normalized by institutional guidelines
• Improvement or resolution in renal and / or neurologic dysfunction

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
29	4/24/2026	Add	Added red warning box above question 29 to clarify the question apply only to 100d and 6 month timepoints: Thrombotic Microangiopathy (TMA) questions can only be completed on the 100-day and 6-month follow-up forms. These questions will be disabled for all subsequent reporting periods.	Added for clarification

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