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TerminatedNCT02050230Updated Oct 27, 2016

Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

A Phase 4 interventional study of Blood transfusion in Pulmonary Hypertension, sponsored by Medical University of Vienna. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment

Why this study was terminated
Protracted recruitment of patients
Phase
Phase 4
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • transfusion
  • pulmonary hypertension
  • intensive care medicine
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 11 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patient has a pulmonary artery catheter in place
  2. Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
  3. The patient has an arterial catheter

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years
  2. Clinical prediction that the patient will not survive at least 48 hours
  3. Acute bleeding: > 2 units of packed red blood cells/hour
  4. Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
  5. Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
  6. Sepsis
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    Fresh blood transfusion

    One unit of blood stored for less than 14 days

    Biological: Blood transfusion

  • Experimental
    Standard issue blood transfusion

    One unit of blood stored under standard conditions

    Biological: Blood transfusion

Interventions

  • BiologicalBlood transfusion

    One unit of red blood cells will be transfused over the course of 20 minutes

06

What researchers measure

Primary outcomes

  1. Pulmonary arterial pressure

    Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)

  2. Pulmonary vascular resistance

    Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)

Secondary outcomes

  1. Systemic pressure

    Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)

  2. Systemic vascular resistance

    Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)

07

Study locations

1 site
  • General Hospital of the Medical University of Vienna
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02050230
Lead sponsor
Medical University of Vienna
Responsible party
David M Baron, MD (MD, Medical University of Vienna) — Principal investigator
First posted
Jan 30, 2014
Start date
Jan 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Oct 27, 2016

Study contacts

Roman Ullrich, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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