Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

October 26, 2016 updated by: David M Baron, MD, Medical University of Vienna
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General Hospital of the Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary arterial pressure
Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Change from baseline to immediately after transfusion (time frame of 20 min)
Pulmonary vascular resistance
Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Change from baseline to immediately after transfusion (time frame of 20 min)

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic pressure
Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Change from baseline to immediately after transfusion (time frame of 20 min)
Systemic vascular resistance
Time Frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Change from baseline to immediately after transfusion (time frame of 20 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASG 2013-002316-27
  • 2013-002316-27 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe