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Transfusion Strategies in Weaning Patients (WTT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Krankenhaus Kloster Grafschaft.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier:
NCT01256645
First received: December 7, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 Intervention Phase
Weaning Patients
 Other: blood transfusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liberal Versus Restrictive Transfusion Management in Patients Being Weaned From Prolonged Mechanical Ventilation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Krankenhaus Kloster Grafschaft:

Primary Outcome Measures:
  • Time to sucessfull weaning [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Time between randomisation an sucessfull liberation from invasive mechanical ventilation


Secondary Outcome Measures:
  • mortality [ Time Frame: within hospital ] [ Designated as safety issue: No ]
    mortality during the hospital stay


Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Koehler, Prof. Dr., Kloster Grafschaft
ClinicalTrials.gov Identifier: NCT01256645     History of Changes
Other Study ID Numbers: WT 2010
Study First Received: December 7, 2010
Last Updated: December 7, 2010
Health Authority: Germany: Institut für Lungenforschung

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

ClinicalTrials.gov processed this record on May 16, 2013