AtherosclerosisPhase 2TVNCT02465125
The Transfusion Triggers in Vascular Surgery Trial
A Phase 2 study testing red blood cell transfusion in people with Atherosclerosis and Anemia, run by Naestved Hospital at 1 site in Denmark.
Trial summary
BACKGROUND Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atherosclerosis, Anemia, Aortic Aneurysm, Abdominal
- What is being tested?
- red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jul 2015to 9 Jan 2017
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for planned open repair of the abdominal aorta or infrainguinal arterial bypass
- Hemoglobin < 6 mmol/L
Who cannot join
- Documented wish against transfusion
- Previous serious adverse reaction with blood products
- Unable to understand the benefits and risks of testing
- Previous participation in trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Transfusion Triggers in Vascular Surgery Trial: Two Different Transfusion Triggers for Postoperative Haemoglobin Separation and Adherence to Transfusion Strategies in Vascular Surgery: a Randomised Clinical Feasibility Trial
BACKGROUND
- Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period
- RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful
- Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain hemoglobin levels above 6 mmol/L
- A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC transfusion in patients undergoing vascular surgery.
- A trial examining the effect of RBC transfusion on tissue oxygenation is used to test the trial-design and feasibility for a trial evaluating post-operative mortality and morbidity.
Read the detailed description
DESIGN Single-center, randomized, open-label trial including vascular surgical patients for peri-operative red blood cell (RBC) transfusion.
If the patient drops out of the trial, either at his/her own request or due to withdrawal from active therapy, the patient will be followed up in the intention-to-treat analyses.
PROTOCOL SUSPENSION
The patient can temporarily be suspended from the protocol in the following circumstances, if the clinician in charge finds indication for blood transfusions not adhering to the planned transfusion threshold:
- Uncontrollable bleeding, defined as loss of surgical hemostasis resulting in overt or imminent hemodynamic instability with insufficient tissue oxygenation and increasing lactate production OR
- Hypotension unresponsive to fluid replacement OR
- Decompensated heart failure OR
- Stroke, extremity- and intestinal ischaemia
SAMPLE SIZE With a total of 50 randomised patients, the trial is powered to
- Show difference in mean postoperative hemoglobin of 1.0 mmol/L. With a power of 95%, 5% significance and a standard deviation of 0.9 mmol/L.
- Show a difference in 2 units (600 mL) of RBC transfused based on a standard deviation of RBC transfusion volume of 717 mL, with a power of 80 % and 5% significance
- Produce a 97.5% confidence interval (CI) equal to the sample adherence prevalence plus or minus 8% when the true prevalence of adherence is hypothesized to be 90%
- Detect a difference in near infrared spectroscopy-determined tissue oxygenation (ScO2) of 6 % during surgery. With a power of 80%, 5% significance and a ScO2-standard deviation of 7%
TIME-LINE The first patient is expected to be randomized June 8th 2015, the last will be randomized March 31st 2016 and the trial database is expected to be closed ultimo June 2016. The main manuscript will be submitted shortly thereafter.
PROTOCOL AMENDMENTS
- The Ethical Committee of Region Zealand has approved a protocol amendment of March 29th 2016 for permission of extending the trial period to the end of 2016.
- On September 20th 2016 The Ethical Committee of Region Zealand approved a protocol amendment of September 16th 2016 for permission of extending the sample size to 58 patients and extending the trial period to June 31st 2017.
The 2nd amendment was submitted to compensate for an unexpected high rate of patients randomised postoperatively and thus to secure a sufficient sample size (n=44) for the primary outcome measure, postoperative Hb, and the secondary outcome measures NIRS and ROTEM.
- Being tested
- red blood cell transfusion
- Medical subject headings
- Atherosclerosis, Anemia, Aortic Aneurysm, Abdominal, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red blood cell transfusionBiological
Also called erythrocyte transfusion
| Study group | Role | What they receive |
|---|---|---|
| Low transfusion trigger | Active comparator | Intervention group. Low or restrictive transfusion trigger: hemoglobin < 5 mmol/L (approx. 8 g/dl or a hematocrit of 25%) This trigger is what is recommended by the Danish Health and Medicines Authority for stable patients with chronic heart disease. Receives: Biological: red blood cell transfusion |
| High transfusion trigger | Active comparator | Control group. High or liberal transfusion trigger: hemoglobin < 6 mmol/L (approx. 10 g/dl or a hematocrit of 30%) This trigger reflects the practice among Danish vascular anesthesiologists and correspond to the transfusion trigger recommended by the European society for vascular surgery Receives: Biological: red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Post-operative hemoglobin (longitudinal outcome)
Day 0 is the hemoglobin measured upon arrival at the recovery room or at the intensive care unit depending on what level of care the patient needs after surgery.
Measured: Day 0 - 15
Secondary outcomes (8)
Units of red blood cells transfused (count data)
During 30 day trial period
Measured: 30 days after operation
Recruitment rate with 95% confidence interval
Defined as the ratio of: number of patients included divided by the number of patients eligible (fulfilling the inclusion criteria)
Measured: Day -1 (day before operation)
Protocol suspension
Number of patients having their protocol suspended after primary inclusion due to hemodynamic instability
Measured: 30 days after operation
Protocol adherence
Adherence to hemoglobin concentrations used for transfusion triggers
Measured: 30 days after operation
Intraoperative tissue oxygenation
The outcome measure is defined as lowest values and area-under-baseline calculations. Baseline is defined as the average saturation value over a 1-min period after the patient has been fluid optimized after induction of anesthesia, before start of surgery.
Measured: Participants will be monitored during their stay at the operation theatre, an expected average of 3 hours
Changes in coagulation competence measured by rotational thromboelastometry (ROTEM)
Changes in coagulation competence will be the baseline ROTEM level (before induction of anesthesia) compared to the end of surgery ROTEM level.
Measured: An expected average time frame of 3 hours
Severe adverse events
myocardial injury, acute kidney injury, 30-days mortality, ischemic stroke, severe adverse transfusion reactions
Measured: 30 days after operation
Explorative Outcomes
- Major cardiovascular events (acute myocardial infarction, stroke, renal replacement therapy, vascular reoperation and amputation) (dichotomous outcome) AND
- Days alive outside hospital within 90 days (count data)
Measured: 90 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start15 Jul 2015
- Primary completion8 Dec 2016
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, Research Unit, Naestved, Region Zealand, Denmark.
- Responsible party
- Principal investigator, Anders Møller, Slagelse Hospital
- Investigators
- Anders Møller, Resident, Principal investigator, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465125
- Sponsor's protocol ID
- SJ-426
- Acronym
- TV
- Status last verified
- Jul 2017
- First submitted
- 1 Jun 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836Moller A, Nielsen HB, Wetterslev J, Pedersen OB, Hellemann D, Winkel P, Marcussen KV, Ramsing BGU, Mortensen A, Jakobsen JC, Shahidi S. Low vs high hemoglobin trigger for transfusion in vascular surgery: a randomized clinical feasibility trial. Blood. 2019 Jun 20;133(25):2639-2650. doi: 10.1182/blood-2018-10-877530. Epub 2019 Mar 11.
PubMed 30858230
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transfusion Triggers in Vascular Surgery Trial: Two Different Transfusion Triggers for Postoperative Haemoglobin Separation and Adherence to Transfusion Strategies in Vascular Surgery: a Randomised Clinical Feasibility Trial
- ClinicalTrials.gov ID
- NCT02465125
- Acronym / sponsor ID
- TV / SJ-426
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research, Research Unit, Naestved, Region Zealand, Denmark.
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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.
BACKGROUND
- Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period
- RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful
- Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain hemoglobin levels above 6 mmol/L
- A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC transfusion in patients undergoing vascular surgery.
- A trial examining the effect of RBC transfusion on tissue oxygenation is used to test the trial-design and feasibility for a trial evaluating post-operative mortality and morbidity.
Detailed description
DESIGN Single-center, randomized, open-label trial including vascular surgical patients for peri-operative red blood cell (RBC) transfusion.
If the patient drops out of the trial, either at his/her own request or due to withdrawal from active therapy, the patient will be followed up in the intention-to-treat analyses.
PROTOCOL SUSPENSION
The patient can temporarily be suspended from the protocol in the following circumstances, if the clinician in charge finds indication for blood transfusions not adhering to the planned transfusion threshold:
- Uncontrollable bleeding, defined as loss of surgical hemostasis resulting in overt or imminent hemodynamic instability with insufficient tissue oxygenation and increasing lactate production OR
- Hypotension unresponsive to fluid replacement OR
- Decompensated heart failure OR
- Stroke, extremity- and intestinal ischaemia
SAMPLE SIZE With a total of 50 randomised patients, the trial is powered to
- Show difference in mean postoperative hemoglobin of 1.0 mmol/L. With a power of 95%, 5% significance and a standard deviation of 0.9 mmol/L.
- Show a difference in 2 units (600 mL) of RBC transfused based on a standard deviation of RBC transfusion volume of 717 mL, with a power of 80 % and 5% significance
- Produce a 97.5% confidence interval (CI) equal to the sample adherence prevalence plus or minus 8% when the true prevalence of adherence is hypothesized to be 90%
- Detect a difference in near infrared spectroscopy-determined tissue oxygenation (ScO2) of 6 % during surgery. With a power of 80%, 5% significance and a ScO2-standard deviation of 7%
TIME-LINE The first patient is expected to be randomized June 8th 2015, the last will be randomized March 31st 2016 and the trial database is expected to be closed ultimo June 2016. The main manuscript will be submitted shortly thereafter.
PROTOCOL AMENDMENTS
- The Ethical Committee of Region Zealand has approved a protocol amendment of March 29th 2016 for permission of extending the trial period to the end of 2016.
- On September 20th 2016 The Ethical Committee of Region Zealand approved a protocol amendment of September 16th 2016 for permission of extending the sample size to 58 patients and extending the trial period to June 31st 2017.
The 2nd amendment was submitted to compensate for an unexpected high rate of patients randomised postoperatively and thus to secure a sufficient sample size (n=44) for the primary outcome measure, postoperative Hb, and the secondary outcome measures NIRS and ROTEM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low transfusion trigger | Active comparator | Biological: red blood cell transfusionIntervention group. Low or restrictive transfusion trigger: hemoglobin < 5 mmol/L (approx. 8 g/dl or a hematocrit of 25%) This trigger is what is recommended by the Danish Health and Medicines Authority for stable patients with chronic heart disease. |
| High transfusion trigger | Active comparator | Biological: red blood cell transfusionControl group. High or liberal transfusion trigger: hemoglobin < 6 mmol/L (approx. 10 g/dl or a hematocrit of 30%) This trigger reflects the practice among Danish vascular anesthesiologists and correspond to the transfusion trigger recommended by the European society for vascular surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients for planned open repair of the abdominal aorta or infrainguinal arterial bypass
- Hemoglobin < 6 mmol/L
Key exclusion criteria (4 listed)
- Documented wish against transfusion
- Previous serious adverse reaction with blood products
- Unable to understand the benefits and risks of testing
- Previous participation in trial
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 |
|---|---|---|
| red blood cell transfusionAlso: erythrocyte transfusion | Biological | High transfusion trigger, Low transfusion trigger |
Primary outcome
Mean Post-operative hemoglobin (longitudinal outcome)
Time frame: Day 0 - 15
Day 0 is the hemoglobin measured upon arrival at the recovery room or at the intensive care unit depending on what level of care the patient needs after surgery.
8 secondary outcomes
Units of red blood cells transfused (count data)
Time frame: 30 days after operation
Recruitment rate with 95% confidence interval
Time frame: Day -1 (day before operation)
Protocol suspension
Time frame: 30 days after operation
Protocol adherence
Time frame: 30 days after operation
Intraoperative tissue oxygenation
Time frame: Participants will be monitored during their stay at the operation theatre, an expected average of 3 hours
Changes in coagulation competence measured by rotational thromboelastometry (ROTEM)
Time frame: An expected average time frame of 3 hours
Severe adverse events
Time frame: 30 days after operation
Explorative Outcomes
Time frame: 90 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
- Derived from this study: PubMed 30858230Moller A, Nielsen HB, Wetterslev J, Pedersen OB, Hellemann D, Winkel P, Marcussen KV, Ramsing BGU, Mortensen A, Jakobsen JC, Shahidi S. Low vs high hemoglobin trigger for transfusion in vascular surgery: a randomized clinical feasibility trial. Blood. 2019 Jun 20;133(25):2639-2650. doi: 10.1182/blood-2018-10-877530. Epub 2019 Mar 11.
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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.
Anders Møller, Resident principal investigator
Slagelse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing red blood cell transfusion in people with Atherosclerosis and Anemia, run by Naestved Hospital at 1 site in Denmark.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jul 2017. 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean Post-operative hemoglobin (longitudinal outcome) (time frame: Day 0 - 15). 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 NCT02465125, which also lists 3 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 25 Jul 2017.