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.
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.
Germany1 site, 1 recruiting
- 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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Sato, T, EJ BedrickandC Tsai, Model Selection for Multivariate Regression in Small Samples. Biometrics, 1998. 54(1): p. 391.
- Conditions
- Weaning Patients
- 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 group | Role | What they receive |
|---|---|---|
| restrictive transfusion | No intervention | No transfusion given to correct anemia unless vital indication is given |
| liberal transfusion | Experimental | transfusions 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.
Time to sucessfull weaning
Time between randomisation an sucessfull liberation from invasive mechanical ventilation
Measured: 14 days
Secondary outcomes (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.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weaning PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Kloster Grafschaft
- Sponsor type
- University, hospital or other
- Investigators
- Dieter Köhler, Prof, Study chair, FKKGDominic Dellweg, M.D., Principal investigator, FKKGThomas Barchfeld, M.D., Principal investigator, FKKG
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 9534644Schonhofer 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Versus Restrictive Transfusion Management in Patients Being Weaned From Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01256645
- Acronym / sponsor ID
- WTT / WT 2010
- Conditions
- Weaning Patients
- Keywords
- weaning, mechanical ventilation, blood transfusion, spontaneous breathing trials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Krankenhaus Kloster GrafschaftUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning from the ventilator. Anaesthesia, 1998. 53(2): p. 181.
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.
- 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.
- 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.
- 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.
- Sato, T, EJ BedrickandC Tsai, Model Selection for Multivariate Regression in Small Samples. Biometrics, 1998. 54(1): p. 391.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restrictive transfusion | No intervention | –No transfusion given to correct anemia unless vital indication is given |
| liberal transfusion | Experimental | Other: blood transfusiontransfusions are given in single units until Hb is > 12 mg/dl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hb < 9g/dl
- Prolonged mechanical ventilation for > 14 days
- Hemodynamically stable / no acute ongoing disease
- weainingfailure
- spontaneous breathing capacity less than four hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood transfusionapplication of single units of red blood cell transfusions | Other | liberal transfusion |
Primary outcome
Time to sucessfull weaning
Time frame: 14 days
Time between randomisation an sucessfull liberation from invasive mechanical ventilation
1 secondary outcome
mortality
Time frame: within hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
- Background: PubMed 9534644Schonhofer 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.
- Background: PubMed 9824074Schonhofer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Köhler, Prof study chair
FKKG
Dominic Dellweg, M.D. principal investigator
FKKG
Thomas Barchfeld, M.D. principal investigator
FKKG
1 site in 1 country: see every site and its status.
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.