Back to resultsHemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
Primary Purpose
Pulmonary Hypertension
Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Blood transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring transfusion, pulmonary hypertension, intensive care medicine
Eligibility Criteria
Inclusion Criteria:
- The patient has a pulmonary artery catheter in place
- Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
- The patient has an arterial catheter
Exclusion Criteria:
- Age < 18 years
- Clinical prediction that the patient will not survive at least 48 hours
- Acute bleeding: > 2 units of packed red blood cells/hour
- Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
- Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
- Sepsis
Sites / Locations
- General Hospital of the Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fresh blood transfusion
Standard issue blood transfusion
Arm Description
One unit of blood stored for less than 14 days
One unit of blood stored under standard conditions
Outcomes
Primary Outcome Measures
Pulmonary arterial pressure
Pulmonary vascular resistance
Secondary Outcome Measures
Systemic pressure
Systemic vascular resistance
Full Information
NCT ID
NCT02050230
First Posted
January 17, 2014
Last Updated
October 26, 2016
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02050230
Brief Title
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
Official Title
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Protracted recruitment of patients
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
transfusion, pulmonary hypertension, intensive care medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fresh blood transfusion
Arm Type
Active Comparator
Arm Description
One unit of blood stored for less than 14 days
Arm Title
Standard issue blood transfusion
Arm Type
Experimental
Arm Description
One unit of blood stored under standard conditions
Intervention Type
Biological
Intervention Name(s)
Blood transfusion
Intervention Description
One unit of red blood cells will be transfused over the course of 20 minutes
Primary Outcome Measure Information:
Title
Pulmonary arterial pressure
Time Frame
Change from baseline to immediately after transfusion (time frame of 20 min)
Title
Pulmonary vascular resistance
Time Frame
Change from baseline to immediately after transfusion (time frame of 20 min)
Secondary Outcome Measure Information:
Title
Systemic pressure
Time Frame
Change from baseline to immediately after transfusion (time frame of 20 min)
Title
Systemic vascular resistance
Time Frame
Change from baseline to immediately after transfusion (time frame of 20 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has a pulmonary artery catheter in place
Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
The patient has an arterial catheter
Exclusion Criteria:
Age < 18 years
Clinical prediction that the patient will not survive at least 48 hours
Acute bleeding: > 2 units of packed red blood cells/hour
Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
Sepsis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ullrich, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of the Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
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Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
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