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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
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Biological: Blood transfusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: January 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fresh blood transfusion
One unit of blood stored for less than 14 days
Biological: Blood transfusion
One unit of red blood cells will be transfused over the course of 20 minutes
Experimental: Standard issue blood transfusion
One unit of blood stored under standard conditions
Biological: Blood transfusion
One unit of red blood cells will be transfused over the course of 20 minutes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050230

Contacts
Contact: David M Baron, MD 0043140400 ext 4100 david.baron@meduniwien.ac.at

Locations
Austria
General Hospital of the Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: David M Baron, MD         
Sub-Investigator: David M Baron, MD         
Principal Investigator: Roman Ullich, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Roman Ullrich, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: David M Baron, MD, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02050230     History of Changes
Other Study ID Numbers: BASG 2013-002316-27, 2013-002316-27
Study First Received: January 17, 2014
Last Updated: January 30, 2014
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
transfusion
pulmonary hypertension
intensive care medicine

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014