The Transfusion Triggers in Vascular Surgery Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-15

Study Completion Date

2017-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Plasma Transfusion in Major Vascular Surgery

NCT04514575

Aortic Aneurysm, Abdominal Arterial Occlusive Diseases

COMPLETED

Frozen Red Blood Cell Transfusions in Trauma Patients

NCT01038557

Blood Loss Anemia Trauma

COMPLETED NA

Blood Products in Cardiac Surgery

NCT02068755

Anemia Renal Impairment Thrombocytopenia

COMPLETED

Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty

NCT01452581

Arthroplasty, Hip

TERMINATED NA

Establishment of Optimal Transfusion Threshold During Spine Surgery

NCT00967109

Anemia Spine Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

1. 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.
2. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis Anemia Aortic Aneurysm, Abdominal Arterial Occlusive Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low transfusion trigger

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.

Group Type ACTIVE_COMPARATOR

red blood cell transfusion

Intervention Type BIOLOGICAL

High transfusion trigger

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

Group Type ACTIVE_COMPARATOR

red blood cell transfusion

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

red blood cell transfusion

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

erythrocyte transfusion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients for planned open repair of the abdominal aorta or infrainguinal arterial bypass
* Hemoglobin \< 6 mmol/L

Exclusion Criteria

* Documented wish against transfusion
* Previous serious adverse reaction with blood products
* Unable to understand the benefits and risks of testing
* Previous participation in trial

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No