Changes in blood pressure caused by old blood transfusio

Phase 1

Conditions: Anemia
MedDRA version: 16.0Level: PTClassification code 10033359Term: Packed red blood cell transfusionSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2013-002316-27-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

1.Age < 18 years
2.Clinical prediction that the patient will not survive at least 48 hours
3.Acute bleeding: > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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