Q84 – 133: Product Infusion

Question 84: Date of this product infusion

Report the date this product was infused. If the product was infused over multiple days, report the first date of infusion.

Question 85: Was the entire volume of the product received by the center infused?

Indicate if the entire product volume received (all bags or all compartments) by the center was infused. See the examples below for further clarification.

• Example 1: A PBSC product was collected and arrived at the center in four bags. Two of the bags are infused fresh, and the remaining two bags are cryopreserved for future use. Since a portion of the product received was not infused, report No the entire volume of the product received by the center was not infused.
• Example 2: A bone marrow product was collected and arrived at the center in two bags and both bags of the fresh product are infused. As the entire volume of the received product was infused report Yes, the entire volume of the product received by the center was infused.
• Example 3: A PBSC product was collected and arrived at the center in two bags. Both bags were cryopreserved and only one bag was thawed and infused, with the remaining bag still cryopreserved for future use. Since a portion of the product received was not infused, report No, the entire volume of the product received by the center was not infused.
  

Questions 86 – 87: Specify what happened to the reserved portion (check all that apply)

Report on what happened to the reserved portion of the product. Select all that apply.

If Other fate is selected, report the outcome of this product.

Question 88: Time product infusion initiated (24-hour clock)

Report the start time of the infusion, using a 24-hour clock. If multiple bags were infused, report the start time of the infusion of the first bag.

If multiple products were infused, enter the initiation time of the product for which this form is being completed.

Question 89: Date infusion stopped

Report the date the infusion was completed. If multiple bags of the same product were infused, report the stop date of the last bag.

If multiple products were infused, enter the stop date of the product for which this form is being completed.

Question 90: Time product infusion completed (24-hour clock)

If multiple bags of the same product were infused, report the completion time of the last bag, using a 24-hour clock.

If multiple products were infused, enter the completion time of the product for which this form is being completed.

Questions 91 – 92: Specify the route of product infusion

Report the route by which the product was infused.

• Intravenous: Refers to infusion into the veins; examples include infusion via central line or via catheter (DL catheter, central venous catheter).
• Intramedullary (Intraosseous): Refers to infusion into the marrow cavity within a bone, such as directly into the left or right iliac crest.

If the route of infusion is not one of the above options (including intraperitoneal), select Other route of infusion and specify the infusion route.

!Adverse Events
The following questions are applicable to cord blood units only. If this HCT used a non-NMDP allogeneic product, continue with the Donor / Infant Demographic Information section. If this HCT used autologous or NMDP products, submit the form.

Question 93: Were there any adverse events or incidents associated with the stem cell infusion?

Indicate whether any adverse events or incidents occurred as a result of the stem cell infusion using a cord blood product. Report all adverse events regardless of the grade or severity.

If an adverse event occurred, select Yes. If an adverse event did not occur, select No.

A serious adverse event is defined as an event which:

• Led to death,
• Was considered life-threatening,
• Required prolongation of hospitalization,
• Led to persistent or significant disability/incapacity, or
• Led to a congenital anomaly/birth defect
  

If any of the above happened, an Adverse Event Form (Form 3001) must also be completed. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Review Adverse Event reporting in the Data Management Guide.

Questions 94 – 133: Specify the following adverse event(s)

Indicate Yes or No for each adverse event listed. Do not leave any responses blank. If the recipient experienced an expected (in the clinician’s opinion) adverse event that was not listed, select Yes for Other expected AE and specify. If the recipient experienced an unexpected adverse event (i.e., not one of the options listed above, or an “other expected AE”), select Yes for Other unexpected AE and specify.

For each adverse event that occurred, indicate if the clinician believes the adverse event(s) to be directly related to the infusion of the product.

Flushing / facial flushing and cough should not be reported as an adverse event; however, abdominal pain may be reported (expected or unexpected).

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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