Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Data collection outcome - Ability to provide timely monthly reports |
Ability of each participating site to provide timely monthly reports to monitor inventory levels and mortality outcomes. |
From date of study initiation at each site until 30 days after the final patient is randomized. |
|
| Other |
Data collection outcome - Rate of post-randomization exclusions (%) |
Rate of post-randomization exclusions calculated by taking the number of patient exclusions post randomization divided by the total number randomized x 100%. |
From date the first patient is randomized until 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - In-hospital mortality (%) |
In-hospital mortality calculated by taking the number of deaths in hospital divided by the total number randomized x 100%. |
From date the first patient is randomized until 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - Time to death (days) |
Time to death in days, only applicable to patients who die while in hospital. |
From date of patient randomization until the date of death from any cause while in hospital, assessed up to 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - Hemoglobin increment (g/L) |
Hemoglobin increment calculated by taking the post-transfusion hemoglobin value minus the pre-transfusion hemoglobin value. |
From date of patient randomization until the date of discharge from hospital or date of death from any cause, whichever comes first, assessed up to 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - Creatinine level and increment (umol/L) |
Creatinine increment calculated by taking the post-transfusion creatinine value minus the pre-transfusion creatinine value. |
From date of patient randomization until the date of discharge from hospital or date of death from any cause, whichever comes first, assessed up to 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - ICU/hospital length of stay (days) |
Days admitted to ICU and/or hospital. |
From date of patient randomization until the date of discharge from hospital or date of death from any cause, whichever comes first, assessed up to 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - Number/type of transfused products (unit/volume) |
Number of units and/or volume and type of blood products/plasma derivatives transfused. |
From date of patient randomization until the date of discharge from hospital or date of death from any cause, whichever comes first, assessed up to 30 days after the final patient is randomized. |
|
| Other |
Patient important clinical outcomes - Number/type of transfusion reactions |
Number and type of transfusion reactions reported. |
From date of patient randomization until the date of discharge from hospital or date of death from any cause, whichever comes first, assessed up to 30 days after the final patient is randomized. |
|
| Primary |
Feasibility outcome - Missing randomization rate (%) |
Feasibility of randomizing consecutive eligible patients in the intensive care unit who require blood transfusion. Data collected electronically at monthly intervals. Missing randomization rate calculated by taking the number of eligible patients not randomized divided by the total number of eligible patients × 100%. |
From date of study initiation at each site until date the final patient is randomized, approximately 8 months. |
|
| Primary |
Feasibility outcome - Recruitment compliance (%) |
Number of recruitments that are compliant out of all randomizations. Reasons for recruitment non-compliance include: (a) duplicate randomization; (b) entering incorrect identification number into the randomization program; (c) patient randomized not admitted to ICU; and, (d) randomized ICU patients not transfused. Data collected electronically at monthly intervals. Frequency of recruitment compliance calculated by taking the number of recruitments that are compliant divided by the total number of patients randomized ×100%. |
From date the first patient is randomized until 30 days after the final patient is randomized. |
|
| Primary |
Feasibility outcome - Protocol adherence (%) |
The proportion of patients in the intervention arms who receive all red blood cell transfusions as sex-matched/sex-mismatched out of all transfused per intervention arm. Data collected electronically at monthly intervals. Percentage protocol adherence rate calculated by taking the number of patients in the intervention arm who receive all RBC transfusions as sex-matched or mismatched divided by the total number of transfused patients in the intervention arm x 100%. |
From date the first patient is randomized until 30 days after the final patient is randomized. |
|
