Red Blood Cell TransfusionPhase 4iTADSNCT03344887
An Innovative Trial Assessing Donor Sex on Recipient Mortality
A Phase 4 study testing RBC Transfusion from male donor and RBC Transfusion from female donor in people with Red Blood Cell Transfusion, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The iTADS trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Red Blood Cell Transfusion
- What is being tested?
- RBC Transfusion from male donor and RBC Transfusion from female donor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,850 participants
- Where
- 1 siteCanada
- Study dates
- 4 Sep 2018to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.
Who cannot join
- Patients that do not have a valid Ontario Health Insurance Plan (OHIP) number at time of first transfusion
- Patients that require emergent release of a RBC transfusion and in whom emergency randomization could not be completed
- Patients with complex antibody profile in which it is impossible to match RBC units
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)
The iTADS trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood.
The trial will help determine how the investigators can tailor the selection of blood donors based on donor characteristics (e.g. sex) to further improve the safety and optimize the clinical benefit of blood products in Canada.
Read the detailed description
The investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions.
Primary objective:
To confirm that a transfusion strategy of receiving male donor RBC (Red Blood Cell) units only will improve survival compared to a transfusion strategy of female donor RBC units in all hospital patients requiring a transfusion.
Secondary objectives:
- To assess effects of male RBC units on major morbidities (cancer, infection, end-organ damage)
- To assess effects across major patient subgroups (major surgery, intensive care, oncology)
- To assess the effect of female donor pregnancy history on recipient transfusion outcome
- To build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.
- Conditions
- Red Blood Cell Transfusion
- Being tested
- RBC Transfusion from male donor, RBC Transfusion from female donor
- Keywords
- anemia, donor sex, prospective blinded pragmatic randomized
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBC Transfusion from male donorOther
Patients requiring an RBC transfusion for the treatment of anemia will receive products from a male donor at initial and any subsequent hospitalizations during the trial period.
RBC Transfusion from female donorOther
Patients requiring an RBC transfusion for the treatment of anemia will receive products from a female donor at initial and any subsequent hospitalizations during the trial period.
| Study group | Role | What they receive |
|---|---|---|
| RBC Transfusion from male donor | Active comparator | For the treatment of anemia Receives: Other: RBC Transfusion from male donor |
| RBC Transfusion from female donor | Active comparator | For the treatment of anemia Receives: Other: RBC Transfusion from female donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.
Measured: 2 years
Secondary outcomes (10)
Survival
Measured from date of first randomization to date of death or end of study 2 years from the first patient enrollment.
Measured: 30 days, 3 months, 6 months and 1 year
Length of hospital stay
Number of days admitted to hospital for the treatment of anemia.
Measured: 2 years
New ICU admission
Occurrence of ICU admission(s) once discharged for the treatment of anemia.
Measured: 2 years
Re-hospitalization
Occurrence of additional hospital admission(s) once discharged for the treatment of anemia.
Measured: 2 years
Health system costs
The cost of the treatment of anemia and any related downstream health care resources.
Measured: 2 years
Occurrence of new cancer
The number of new cancer diagnoses, not present during the initial treatment of anemia.
Measured: 2 years
Recurrence of cancer
The number of repeat cancer diagnoses, diagnosed previous to the initial treatment of anemia.
Measured: 2 years
Infection rates
Methicillin-resistant Staphylococcus aureus and Clostridium difficile for hospital-acquired infections.
Measured: 2 years
New occurrence of hemodialysis
For severe chronic renal failure.
Measured: 2 years
Myocardial infarctions
For cardiac events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start4 Sep 2018
- Primary completion23 Jan 2021
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Red Blood Cell TransfusionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Blood Services
- Responsible party
- Sponsor
- Investigators
- Michaël Chassé, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Dean Fergusson, Principal investigator, Ottawa Hospital Research InstituteAlan Tinmouth, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344887
- Sponsor's protocol ID
- 20170477-01H
- Acronym
- iTADS
- Status last verified
- Jun 2022
- First submitted
- 14 Nov 2017
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chasse M, Fergusson DA, Tinmouth A, Acker JP, Perelman I, Tuttle A, English SW, Hawken S, Forster AJ, Shehata N, Thavorn K, Wilson K, Cober N, Maddison H, Tokessy M. Effect of Donor Sex on Recipient Mortality in Transfusion. N Engl J Med. 2023 Apr 13;388(15):1386-1395. doi: 10.1056/NEJMoa2211523.
PubMed 37043654Fergusson DA, Chasse M, Tinmouth A, Acker JP, English S, Forster AJ, Hawken S, Shehata N, Thavorn K, Wilson K, Tuttle A, Perelman I, Cober N, Maddison H, Tokessy M. Pragmatic, double-blind, randomised trial evaluating the impact of red blood cell donor sex on recipient mortality in an academic hospital population: the innovative Trial Assessing Donor Sex (iTADS) protocol. BMJ Open. 2021 Feb 23;11(2):e049598. doi: 10.1136/bmjopen-2021-049598.
PubMed 33622960
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)
- ClinicalTrials.gov ID
- NCT03344887
- Acronym / sponsor ID
- iTADS / 20170477-01H
- Conditions
- Red Blood Cell Transfusion
- Keywords
- anemia, donor sex, prospective blinded pragmatic randomized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,850 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Blood Services
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The iTADS trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood.
The trial will help determine how the investigators can tailor the selection of blood donors based on donor characteristics (e.g. sex) to further improve the safety and optimize the clinical benefit of blood products in Canada.
Detailed description
The investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions.
Primary objective:
To confirm that a transfusion strategy of receiving male donor RBC (Red Blood Cell) units only will improve survival compared to a transfusion strategy of female donor RBC units in all hospital patients requiring a transfusion.
Secondary objectives:
- To assess effects of male RBC units on major morbidities (cancer, infection, end-organ damage)
- To assess effects across major patient subgroups (major surgery, intensive care, oncology)
- To assess the effect of female donor pregnancy history on recipient transfusion outcome
- To build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBC Transfusion from male donor | Active comparator | Other: RBC Transfusion from male donorFor the treatment of anemia |
| RBC Transfusion from female donor | Active comparator | Other: RBC Transfusion from female donorFor the treatment of anemia |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.
Key exclusion criteria (3 listed)
- Patients that do not have a valid Ontario Health Insurance Plan (OHIP) number at time of first transfusion
- Patients that require emergent release of a RBC transfusion and in whom emergency randomization could not be completed
- Patients with complex antibody profile in which it is impossible to match RBC units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBC Transfusion from male donorPatients requiring an RBC transfusion for the treatment of anemia will receive products from a male donor at initial and any subsequent hospitalizations during the trial period. | Other | RBC Transfusion from male donor |
| RBC Transfusion from female donorPatients requiring an RBC transfusion for the treatment of anemia will receive products from a female donor at initial and any subsequent hospitalizations during the trial period. | Other | RBC Transfusion from female donor |
Primary outcome
Survival
Time frame: 2 years
Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.
10 secondary outcomes
Survival
Time frame: 30 days, 3 months, 6 months and 1 year
Length of hospital stay
Time frame: 2 years
New ICU admission
Time frame: 2 years
Re-hospitalization
Time frame: 2 years
Health system costs
Time frame: 2 years
Occurrence of new cancer
Time frame: 2 years
Recurrence of cancer
Time frame: 2 years
Infection rates
Time frame: 2 years
New occurrence of hemodialysis
Time frame: 2 years
Myocardial infarctions
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Derived from this study: PubMed 37043654Chasse M, Fergusson DA, Tinmouth A, Acker JP, Perelman I, Tuttle A, English SW, Hawken S, Forster AJ, Shehata N, Thavorn K, Wilson K, Cober N, Maddison H, Tokessy M. Effect of Donor Sex on Recipient Mortality in Transfusion. N Engl J Med. 2023 Apr 13;388(15):1386-1395. doi: 10.1056/NEJMoa2211523.
- Derived from this study: PubMed 33622960Fergusson DA, Chasse M, Tinmouth A, Acker JP, English S, Forster AJ, Hawken S, Shehata N, Thavorn K, Wilson K, Tuttle A, Perelman I, Cober N, Maddison H, Tokessy M. Pragmatic, double-blind, randomised trial evaluating the impact of red blood cell donor sex on recipient mortality in an academic hospital population: the innovative Trial Assessing Donor Sex (iTADS) protocol. BMJ Open. 2021 Feb 23;11(2):e049598. doi: 10.1136/bmjopen-2021-049598.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaël Chassé principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Dean Fergusson principal investigator
Ottawa Hospital Research Institute
Alan Tinmouth principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RBC Transfusion from male donor and RBC Transfusion from female donor in people with Red Blood Cell Transfusion, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.