Changes in blood pressure caused by old blood transfusion

Hemodynamic effects of stored blood transfusion in intensive care patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002316-27-AT

Enrollment

Unknown

Registered

2013-08-06

Start date

2013-08-27

Completion date

Unknown

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia MedDRA version: 16.0 Level: PT Classification code 10033359 Term: Packed red blood cell transfusion System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Packed red blood cells Product Name: Packed red blood cells Product Code: B03 Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: 1. Age 2 units of PRBCs/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 PDE-5-inhibitors 6. Sepsis

Design outcomes

Primary

Measure	Time frame
Main Objective: We want to study whether duration of storage of packed red blood cells has an effect on pulmonary arterial pressure and pulmonary vascular resistance;Secondary Objective: We want to study whether duration of storage of packed red blood cells has an effect on systemic arterial pressure and pulmonary vascular resistance, as well as cardiac output and free hemoglobin concentrations;Primary end point(s): Difference in pulmonary arterial pressure between begin and end of transfusion;Timepoint(s) of evaluation of this end point: T=0min (begin of transfusion) and T=15min (end of transfusion)	—

Measure

Time frame

Main Objective: We want to study whether duration of storage of packed red blood cells has an effect on pulmonary arterial pressure and pulmonary vascular resistance;Secondary Objective: We want to study whether duration of storage of packed red blood cells has an effect on systemic arterial pressure and pulmonary vascular resistance, as well as cardiac output and free hemoglobin concentrations;Primary end point(s): Difference in pulmonary arterial pressure between begin and end of transfusion;Timepoint(s) of evaluation of this end point: T=0min (begin of transfusion) and T=15min (end of transfusion)

—

Secondary

Measure	Time frame
Secondary end point(s): Difference in pulmonary vascular resistance, systemic arterial pressue, systemic vascular resistance, and cardiac output between begin and end of transfusion. Difference in free hemoglobin concentration between begin and end of transfusion. Correlation between the increase in pulmonary arterial pressure and free hemoglobin at the end of transfusion. Comparison of following lab parameters in both study groups: erythrocytes, hematocrit, hemoglobin, leukocytes, platelets, glucose, creatinine, BUN, GOT, GPT, AP, Na, K, bilirubin. Follow-up of all parameters for an additional 45 min after the end of transfusion. Should the primary end point be positiv we will perform a „Nitric oxide consumption assay“ ;Timepoint(s) of evaluation of this end point: T=0min (begin of transfusion), T=15min (end of transfusion), and T=60min (follow-up)	—

Measure

Time frame

Secondary end point(s): Difference in pulmonary vascular resistance, systemic arterial pressue, systemic vascular resistance, and cardiac output between begin and end of transfusion. Difference in free hemoglobin concentration between begin and end of transfusion. Correlation between the increase in pulmonary arterial pressure and free hemoglobin at the end of transfusion. Comparison of following lab parameters in both study groups: erythrocytes, hematocrit, hemoglobin, leukocytes, platelets, glucose, creatinine, BUN, GOT, GPT, AP, Na, K, bilirubin. Follow-up of all parameters for an additional 45 min after the end of transfusion. Should the primary end point be positiv we will perform a „Nitric oxide consumption assay“ ;Timepoint(s) of evaluation of this end point: T=0min (begin of transfusion), T=15min (end of transfusion), and T=60min (follow-up)

—

Countries

Austria

Contacts

Public ContactDr. David Baron

Medizinische universität Wien

david.baron@meduniwien.ac.at00436502470850

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026