NCT02050230

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

January 17, 2014

Last Update Submit

October 26, 2016

Conditions

Pulmonary Hypertension

Keywords

transfusionpulmonary hypertensionintensive care medicine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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)

Study Arms (2)

Fresh blood transfusion

ACTIVE COMPARATOR

One unit of blood stored for less than 14 days

Biological: Blood transfusion

Standard issue blood transfusion

EXPERIMENTAL

One unit of blood stored under standard conditions

Biological: Blood transfusion

Interventions

Blood transfusionBIOLOGICAL

One unit of red blood cells will be transfused over the course of 20 minutes

Fresh blood transfusionStandard issue blood transfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient has a pulmonary artery catheter in place
  • Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
  • The patient has an arterial catheter

You may not qualify if:

  • Age \< 18 years
  • Clinical prediction that the patient will not survive at least 48 hours
  • Acute bleeding: \> 2 units of packed red blood cells/hour
  • Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
  • Sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of the Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Roman Ullrich, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

AU(1)