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The Transfusion Triggers in Vascular Surgery Trial

NCT02465125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-07-25

No results posted yet for this study

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

Interventions

BIOLOGICAL

red blood cell transfusion

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Research Unit, Naestved, Region Zealand, Denmark.

    collaborator UNKNOWN

  • Naestved Hospital

    lead OTHER

Principal Investigators

  • Anders Møller, Resident · Slagelse Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-15
Primary Completion
2016-12-08
Completion
2017-01-09

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465125 on ClinicalTrials.gov