Trial · NCT01638416
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
NCT01638416, Phase 3, Completed, Australian and New Zealand Intensive Care Research Centre; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial. Trials, record NCT01638416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01638416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
- NCT number
- NCT01638416
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,994 participants, actual
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Conditions
- Transfusion, Age of Blood
- Interventions
- Blood transfusion
- First posted
- 2012-07-11
- Last updated
- 2020-10-22
- Results first posted
- 2020-10-22
- Limitations and caveats
The red-cell age in each treatment group was not prespecified but was determined by the blood-bank inventory at each institution.~We did not design the trial to assign red cells toward the end of their shelf life (35 to 42 days).
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mortality at Day 90 | 90 Day | Mortality at Day 90 |
| Secondary | Mortality at Day 28 | 28 day | Mortality at day 28 |
| Secondary | Persistent Organ Dysfunction Combined With Death Measured at Day 28 | day 28 | Persistent Organ Dysfunction combined with death measured at day 28 |
| Secondary | Days Alive and Free of Mechanical Ventilation | day 28 | Days alive and free of mechanical ventilation |
| Secondary | Day Alive and Free of Renal Replacement Therapy. | day 28 | Day alive and free of renal replacement therapy. |
| Secondary | Blood Stream Infection in ICU (Post Randomisation) | While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4) | Blood stream infection in ICU (post randomisation) Time Frame is in Days |
| Secondary | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3) | Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days |
| Secondary | Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4) | Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU |
| Secondary | EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation | Day 180 | EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mortality at Day 90 | 90 Day | Pre specified Sub groups | participants | NUMBER |
| SECONDARY | Mortality at Day 28 | 28 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Persistent Organ Dysfunction Combined With Death Measured at Day 28 | day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Days Alive and Free of Mechanical Ventilation | day 28 | days | MEDIAN | |
| SECONDARY | Day Alive and Free of Renal Replacement Therapy. | day 28 | days | MEDIAN | |
| SECONDARY | Blood Stream Infection in ICU (Post Randomisation) | While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3) | Days | MEDIAN | |
| SECONDARY | Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation | Day 180 |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mortality at Day 90 | Arm B (Short Term Storage) | All patients | 610 | participants | |
| Mortality at Day 90 | Standard of Care (Long Term Storage) | All patients | 594 | participants | |
| Mortality at Day 90 | Arm B (Short Term Storage) | Group O | 264 | participants | |
| Mortality at Day 90 | Standard of Care (Long Term Storage) | Group O | 259 | participants | |
| Mortality at Day 90 | Arm B (Short Term Storage) | Non-Group O | 346 | participants | |
| Mortality at Day 90 | Standard of Care (Long Term Storage) | Non-Group O | 335 | participants | |
| Mortality at Day 90 | Arm B (Short Term Storage) | APACHE III risk of Death <21.5% | 152 | participants | |
| Mortality at Day 90 | Standard of Care (Long Term Storage) | APACHE III risk of Death <21.5% | 169 | participants | |
| Mortality at Day 90 | Arm B (Short Term Storage) | APACHE III risk of Death =or>21.5% | 457 | participants | |
| Mortality at Day 90 | Standard of Care (Long Term Storage) | APACHE III risk of Death =or>21.5% | 425 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm B (Short Term Storage) | 2,490 | |
| Overall Study | STARTED | Standard of Care (Long-term Storage) | 2,504 | |
| Overall Study | COMPLETED | Arm B (Short Term Storage) | 2,457 | |
| Overall Study | COMPLETED | Standard of Care (Long-term Storage) | 2,462 | |
| Overall Study | NOT COMPLETED | Arm B (Short Term Storage) | 33 | |
| Overall Study | NOT COMPLETED | Standard of Care (Long-term Storage) | 42 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile Nonhaemolytic transfusion reaction | Immune system disorders | Arm B (Short Term Storage) | 35 | 2,457 | |
| other | Febrile Nonhaemolytic transfusion reaction | Immune system disorders | Standard of Care (Long Term Storage) | 39 | 2,462 | |
| other | New Bloodstream Infection in ICU | Blood and lymphatic system disorders | Arm B (Short Term Storage) | 123 | 2,457 | |
| other | New Bloodstream Infection in ICU | Blood and lymphatic system disorders | Standard of Care (Long Term Storage) | 88 | 2,462 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm B (Short Term Storage) | 687 | 2,410 |
| Total, all-cause mortality | Standard of Care (Long Term Storage) | 678 | 2,414 |
| Total, other adverse events | Arm B (Short Term Storage) | 158 | 2,457 |
| Total, other adverse events | Standard of Care (Long Term Storage) | 127 | 2,462 |
| Total, serious adverse events | Arm B (Short Term Storage) | 0 | 2,457 |
| Total, serious adverse events | Standard of Care (Long Term Storage) | 0 | 2,462 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm B (Short Term Storage) vs Standard of Care (Long Term Storage): Persistent Organ Dysfunction Combined With Death Measured at Day 28 | Trial comparisons |
| Arm B (Short Term Storage) vs Standard of Care (Long-term Storage): Blood Stream Infection in ICU (Post Randomisation) | Trial comparisons |
| Arm B (Short Term Storage) vs Standard of Care (Long Term Storage): Mortality at Day 28 | Trial comparisons |
| Arm B (Short Term Storage) vs Standard of Care (Long-term Storage): Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | Trial comparisons |
| Arm B (Short Term Storage) vs Standard of Care (Long Term Storage): deaths from any cause | Trial comparisons |
| Arm B (Short Term Storage) vs Standard of Care (Long Term Storage): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01638416
GET https://conductscience.org/api/trials/v1/NCT01638416/results?page=2