Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Pulmonary Hypertension Clinical Trial

Official title:

Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02050230
• Other study ID #: BASG 2013-002316-27
• Secondary ID: 2013-002316-27
• Status: Terminated
• Phase: Phase 4
• First received: January 17, 2014
• Last updated: October 26, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Biological:
• Blood transfusion
One unit of red blood cells will be transfused over the course of 20 minutes

Locations

Country	Name	City	State
Austria	General Hospital of the Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary arterial pressure		Change from baseline to immediately after transfusion (time frame of 20 min)	No
Primary	Pulmonary vascular resistance		Change from baseline to immediately after transfusion (time frame of 20 min)	No
Secondary	Systemic pressure		Change from baseline to immediately after transfusion (time frame of 20 min)	No
Secondary	Systemic vascular resistance		Change from baseline to immediately after transfusion (time frame of 20 min)	No