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Weaning PatientsPhase 4WTTNCT01256645

Transfusion Strategies in Weaning Patients

A Phase 4 study testing blood transfusion in people with Weaning Patients, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to determine, whether a liberal transfusion strategy is helpful to liberate patients from prolonged invasive mechanical ventilation. Patients who are difficult to wean according to the criteria by Boles et al [1] are limited by the capacity of their respiratory muscles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weaning Patients
What is being tested?
blood transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGermany
Study dates
Dec 2010to Feb 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hb < 9g/dl
  • Prolonged mechanical ventilation for > 14 days
  • Hemodynamically stable / no acute ongoing disease
  • weainingfailure
  • spontaneous breathing capacity less than four hours
  • Euvolemia
  • Consent

Who cannot join

  • Age < 18 years
  • Pregnancy
  • known blood incompatibility
  • acute indications to give blood products or previous transfusions within the last three days
  • previously known chronic anemia
  • coma
  • ongoing dialysis

Trial locations and contacts

1 site in 1 country.

Dieter Köhler, Prof contact

+49 2972 ext. 2500

d.koehler@fkkg.de

Dominic Dellweg, M.D. contact

+49 2972 ext. 3005

d.dellweg@fkkg.de

Germany1 site, 1 recruiting
  • Kloster Grafschaft

    Schmallenberg, North Rhine-Westphalia, 57392

    Dieter Koehler, Prof, *49 2972 ext. 2500, d.koehler@fkkg.de

    Dominic Dellweg, M.D., +49 2972 ext. 3005, d.dellweg@fkkg.de

    Recruiting

Other trials in Germany

About this study

Official title: Liberal Versus Restrictive Transfusion Management in Patients Being Weaned From Prolonged Mechanical Ventilation

The aim of this study is to determine, whether a liberal transfusion strategy is helpful to liberate patients from prolonged invasive mechanical ventilation.

Patients who are difficult to wean according to the criteria by Boles et al [1] are limited by the capacity of their respiratory muscles.

Read more

Improved oxygen delivery achieved by blood transfusions however is known to decrease the work of breathing [2] and thus in theory can improve weaning success [3].

This study is designed as a prospective, randomized, open labeled blinded End-point evaluation to test the hypothesis that a liberal transfusion strategy decreases the time needed for weaning.

  1. Boles, JM, J Bion, A Connors, M Herridge, B Marsh, C Melot, R Pearl, H Silverman, M Stanchina, A Vieillard-BaronandT Welte, Weaning from mechanical ventilation. Eur Respir J, 2007. 29(5): p. 1033.
  2. Schonhofer, B, M Wenzel, M GeibelandD Kohler, Blood transfusion and lung function in chronically anemic patients with severe chronic obstructive pulmonary disease. Crit Care Med, 1998. 26(11): p. 1824.
  3. Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning from the ventilator. Anaesthesia, 1998. 53(2): p. 181.
Read the detailed description

Liberation from invasive mechanical ventilation has a huge impact on quality of life and healthcare expenses. Weaning is more difficult and complex in patients who have been ventilated for a longer time (i.e. more than seven days) or have undergone multiple failed weaning attempts and thus are classified weaning category three according to Boles at al. [1] Current national and international guidelines are in favour of a rather restrictive transfusion regime. This recommendation is mainly based on the work of Hebert et al. [2] where no benefit or a liberal transfusion approach could be found. Patients in the Hebert study however had become acutely ill and did not show any impairment or dysfunction of the respiratory muscles

Weaning class 3 patients however suffer from an overload of their respiratory muscles either cause by an increased load or decreased capacity.

In either instance unloading of the respiratory muscles is key to improve the capability of spontaneous breathing. One possible way to achieve this goal is to improve oxygen delivery.

Oxygen delivery is determined by the cardiac output times the oxygen content of the blood. The latter is mainly determined by the haemoglobin concentration and the oxygen saturation (Hb x 1.34 x SaO2 + PO2 x 0.003). Previous studies have shown that in patients with a strained respiratory pump blood transfusions improve the work of breathing [3].

A more liberal transfusion strategy therefore might improve the weaning outcome ventilator dependant patients [4]

This study is designed as a prospective, randomized, open labeled blinded End-point evaluation to test the hypothesis that a liberal transfusion strategy decreases the time needed for weaning.

Patients who are anemic (Hb < 9 mg/dl) and were admitted to our specialized weaning unit are either randomized to a conservative or liberal transfusion regime if they are agreed to participate.

The goal in the liberal transfusion group is to keep the Hb at > 12 mg/dl and transfusions are given in single units until this threshold is achieved.

Patients then undergo routine weaning procedures consistent of daily or multiple daily weaning trials paired with intermittent ventilation targeted do rest the respiratory muscles.

Daily physiologic data are recorded as well as adverse events. Primary outcome is the time needed to wean the patients off invasive mechanical ventilation, mortality is a secondary criterium.

The study is planned to include 120 patients in blocks of 40 patients. Interim analysis will be performed after each block and the study will be terminated if a significant result is achieved.

  1. Boles, JM, J Bion, A Connors, M Herridge, B Marsh, C Melot, R Pearl, H Silverman, M Stanchina, A Vieillard-BaronandT Welte, Weaning from mechanical ventilation. Eur Respir J, 2007. 29(5): p. 1033.
  2. Hebert, PC, G Wells, MA Blajchman, J Marshall, C Martin, G Pagliarello, M Tweeddale, I SchweitzerandE Yetisir, A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med, 1999. 340(6): p. 409.
  3. Schonhofer, B, M Wenzel, M GeibelandD Kohler, Blood transfusion and lung function in chronically anemic patients with severe chronic obstructive pulmonary disease. Crit Care Med, 1998. 26(11): p. 1824.
  4. Sato, T, EJ BedrickandC Tsai, Model Selection for Multivariate Regression in Small Samples. Biometrics, 1998. 54(1): p. 391.
Being tested
blood transfusion
Keywords
weaning, mechanical ventilation, blood transfusion, spontaneous breathing trials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood transfusionOther

    application of single units of red blood cell transfusions

Study groups in NCT01256645
Study groupRoleWhat they receive
restrictive transfusionNo interventionNo transfusion given to correct anemia unless vital indication is given
liberal transfusionExperimentaltransfusions are given in single units until Hb is > 12 mg/dl
Receives: Other: blood transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to sucessfull weaning

    Time between randomisation an sucessfull liberation from invasive mechanical ventilation

    Measured: 14 days

Secondary outcomes (1)
  1. mortality

    mortality during the hospital stay

    Measured: within hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionFeb 2013 (estimated)
  4. Study completionFeb 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01256645
Sponsor's protocol ID
WT 2010
Acronym
WTT
Status last verified
Dec 2010
First submitted
7 Dec 2010
Last updated
8 Dec 2010
Results posted
No
Data monitoring committee
No

Publications

  • Schonhofer B, Bohrer H, Kohler D. Blood transfusion facilitating difficult weaning from the ventilator. Anaesthesia. 1998 Feb;53(2):181-4. doi: 10.1046/j.1365-2044.1998.00275.x.

    PubMed 9534644
  • Schonhofer B, Wenzel M, Geibel M, Kohler D. Blood transfusion and lung function in chronically anemic patients with severe chronic obstructive pulmonary disease. Crit Care Med. 1998 Nov;26(11):1824-8. doi: 10.1097/00003246-199811000-00022.

    PubMed 9824074

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing blood transfusion in people with Weaning Patients, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dieter Köhler, Prof (+49 2972 ext. 2500, d.koehler@fkkg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to sucessfull weaning (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256645, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2010.

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