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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Naestved Hospital
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Mean Post-operative hemoglobin (longitudinal outcome)
Study Overview
Brief 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 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: red blood cell transfusion (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
Intervention: red blood cell transfusion (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Explorative Outcomes(90 days after operation)
- Recruitment rate with 95% confidence interval(Day -1 (day before operation))
- Protocol suspension(30 days after operation)
- Units of red blood cells transfused (count data)(30 days after operation)
- Protocol adherence(30 days after operation)
- Changes in coagulation competence measured by rotational thromboelastometry (ROTEM)(An expected average time frame of 3 hours)
- Intraoperative tissue oxygenation(Participants will be monitored during their stay at the operation theatre, an expected average of 3 hours)
- Severe adverse events(30 days after operation)
Investigators
Anders Møller
Resident
Slagelse Hospital