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Transfusion Strategies in Weaning Patients (WTT)

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ClinicalTrials.gov Identifier: NCT01256645
Recruitment Status : Unknown
Verified December 2010 by Krankenhaus Kloster Grafschaft.
Recruitment status was:  Recruiting
First Posted : December 8, 2010
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:
Krankenhaus Kloster Grafschaft

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Weaning Patients Other: blood transfusion Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Liberal Versus Restrictive Transfusion Management in Patients Being Weaned From Prolonged Mechanical Ventilation
Study Start Date : December 2010
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: restrictive transfusion
No transfusion given to correct anemia unless vital indication is given
Experimental: liberal transfusion
transfusions are given in single units until Hb is > 12 mg/dl
Other: blood transfusion
application of single units of red blood cell transfusions




Primary Outcome Measures :
  1. Time to sucessfull weaning [ Time Frame: 14 days ]
    Time between randomisation an sucessfull liberation from invasive mechanical ventilation


Secondary Outcome Measures :
  1. mortality [ Time Frame: within hospital ]
    mortality during the hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256645


Contacts
Contact: Dieter Köhler, Prof +49 2972 ext 2500 d.koehler@fkkg.de
Contact: Dominic Dellweg, M.D. +49 2972 ext 3005 d.dellweg@fkkg.de

Locations
Germany
Kloster Grafschaft Recruiting
Schmallenberg, NRW, Germany, 57392
Contact: Dieter Koehler, Prof    *49 2972 ext 2500    d.koehler@fkkg.de   
Contact: Dominic Dellweg, M.D.    +49 2972 ext 3005    d.dellweg@fkkg.de   
Principal Investigator: Dominic Dellweg, M.D.         
Principal Investigator: Thomas Barchfeld, M.D.         
Sponsors and Collaborators
Krankenhaus Kloster Grafschaft
Investigators
Study Chair: Dieter Köhler, Prof FKKG
Principal Investigator: Dominic Dellweg, M.D. FKKG
Principal Investigator: Thomas Barchfeld, M.D. FKKG

Publications:
Responsible Party: Koehler, Prof. Dr., Kloster Grafschaft
ClinicalTrials.gov Identifier: NCT01256645     History of Changes
Other Study ID Numbers: WT 2010
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Krankenhaus Kloster Grafschaft:
weaning
mechanical ventilation
blood transfusion
spontaneous breathing trials