The Transfusion Triggers in Vascular Surgery Trial

NCT02465125 | Completed Phase 2 DMC

• 1 other identifier: SJ-426
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Anemia; Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 - 15

Secondary Outcomes (8)

• Units of red blood cells transfused (count data)

  30 days after operation

• Recruitment rate with 95% confidence interval

  Day -1 (day before operation)

• Protocol suspension

  30 days after operation

• Protocol adherence

  30 days after operation

• Intraoperative tissue oxygenation

  Participants will be monitored during their stay at the operation theatre, an expected average of 3 hours

Study Arms (2)

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.

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

Biological: red blood cell transfusion

Interventions

red blood cell transfusion BIOLOGICAL

Also known as: erythrocyte transfusion

High transfusion trigger; Low transfusion trigger

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Naestved Hospital: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Research Unit, Naestved, Region Zealand, Denmark.: collaborator

Study Sites (1)

Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (3)

• 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.

  PMID: 41114449 DERIVED

• Carson 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.

  PMID: 34932836 DERIVED

• Moller 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.

  PMID: 30858230 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Anemia; Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Aortic Aneurysm; Aneurysm; Aortic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Anders Møller, Resident

  Slagelse Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: July 15, 2015
• Primary Completion: December 8, 2016
• Study Completion: January 9, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

DK (1)