Outcome evaluation

Monitor for symptoms and signs of the disease that is being treated by HSCT in order to assess the effectiveness of the HSCT. For example, the monitoring plan for a patient with CML would be to monitor disease response by PCR of the BCR-ABL transcript. The actual clinical outcome monitored, along with the frequency of monitoring, is based on the underlying disease.

Monitor for nonhematologic toxicity of the preparative regimen during its administration. Monitor these symptoms at least daily, with more frequent monitoring if the patient is experiencing these nonhematologic effects. The goal is to prevent or minimize these adverse effects. Specifically,

• Busulfan: Seizures, busulfan concentrations if being used with the BU-CY preparative regimen, number of vomiting episodes, and nausea by patient self-report, total bilirubin, and sudden weight changes (sinusoidal obstruction syndrome [SOS])

• Cyclophosphamide: ECG during IV administration, RBCs in urine, frequency of urination, pain on urination, urinary output, number ofvomiting episodes, and nausea by patient self-report, total bilirubin, and sudden weight changes (sinusoidal obstruction syndrome [SOS])

• Etoposide: Blood pressure, respiratory rate, serum pH, serum bicarbonate with arterial blood gases, and evaluation of anion gap if necessary

• Total-body irradiation: Number of vomiting episodes, nausea by patient self-report, sudden weight changes (SOS), total bilirubin, and skin assessment for presence of irritation or blister formation

Until the patient has achieved engraftment, monitor the patient for engraftment with at least daily CBCs with differentials; these tests may be needed more often if the patient is critically ill or had a prior low hemoglobin. Patients will require transfusion support with blood products and platelets until engraftment occurs ifhemoglobin and/ or platelets drop below unsafe levels. Transfusion parameters may differ for individual patients but typically patients will be transfused if the hemoglobin drops below 8 g/dL (4.96 mmol/L); platelets are maintained at least above 10,000/mm3 (10 x 109/L) to prevent spontaneous bleeding.

Until engraftment has occurred, monitor the patient's temperature every 4 to 8 hours for signs of infection. Also guide monitoring signs of focal point of infection based on clinical symptoms. For example, if the patient develops shortness of breath, then imaging of the lungs should occur to assess pulmonary infection. Monitor for the toxicity of prophylaxis and/or treatment of bacterial, fungal, or viral infections.

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