Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

Phase 4

Terminated

• Conditions: Pulmonary Hypertension
• Interventions: Biological: Blood transfusion

• Registration Number: NCT02050230
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh blood transfusion	Blood transfusion	One unit of blood stored for less than 14 days
Standard issue blood transfusion	Blood transfusion	One unit of blood stored under standard conditions

Primary Outcome Measures

Name	Time	Method
Pulmonary arterial pressure	Change from baseline to immediately after transfusion (time frame of 20 min)
Pulmonary vascular resistance	Change from baseline to immediately after transfusion (time frame of 20 min)

Secondary Outcome Measures

Name	Time	Method
Systemic pressure	Change from baseline to immediately after transfusion (time frame of 20 min)
Systemic vascular resistance	Change from baseline to immediately after transfusion (time frame of 20 min)

Trial Locations

Locations (1)

General Hospital of the Medical University of Vienna; 🇦🇹 Vienna, Austria