Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
David M Baron, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02050230
First received: January 17, 2014
Last updated: January 30, 2014
Last verified: January 2014

January 17, 2014
January 30, 2014
January 2014
December 2015   (final data collection date for primary outcome measure)
  • Pulmonary arterial pressure [ Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min) ] [ Designated as safety issue: No ]
  • Pulmonary vascular resistance [ Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02050230 on ClinicalTrials.gov Archive Site
  • Systemic pressure [ Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min) ] [ Designated as safety issue: No ]
  • Systemic vascular resistance [ Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pulmonary Hypertension
Biological: Blood transfusion
One unit of red blood cells will be transfused over the course of 20 minutes
  • Active Comparator: Fresh blood transfusion
    One unit of blood stored for less than 14 days
    Intervention: Biological: Blood transfusion
  • Experimental: Standard issue blood transfusion
    One unit of blood stored under standard conditions
    Intervention: Biological: Blood transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
Not Provided
December 2015   (final data collection date for primary outcome measure)

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:

  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
Both
18 Years and older
No
Contact: David M Baron, MD 0043140400 ext 4100 david.baron@meduniwien.ac.at
Austria
 
NCT02050230
BASG 2013-002316-27, 2013-002316-27
Yes
David M Baron, MD, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Roman Ullrich, MD Medical University of Vienna
Medical University of Vienna
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP