MedDataX Logo

Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients

NCT ID: NCT02050230

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

transfusion pulmonary hypertension intensive care medicine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fresh blood transfusion

One unit of blood stored for less than 14 days

Group Type ACTIVE_COMPARATOR

Blood transfusion

Intervention Type BIOLOGICAL

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

Standard issue blood transfusion

One unit of blood stored under standard conditions

Group Type EXPERIMENTAL

Blood transfusion

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood transfusion

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David M Baron, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roman Ullrich, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General Hospital of the Medical University of Vienna

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-002316-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BASG 2013-002316-27

Identifier Type: -

Identifier Source: org_study_id