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:


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

  Hide Detailed Description

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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014