NCT01256645

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. 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. 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. 3.Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning from the ventilator. Anaesthesia, 1998. 53(2): p. 181.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

2.2 years

First QC Date

December 7, 2010

Last Update Submit

December 7, 2010

Conditions

Weaning Patients

Keywords

weaningmechanical ventilationblood transfusionspontaneous breathing trials

Outcome Measures

Primary Outcomes (1)

  • Time to sucessfull weaning

    Time between randomisation an sucessfull liberation from invasive mechanical ventilation

    14 days

Secondary Outcomes (1)

  • mortality

    within hospital

Study Arms (2)

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

Other: blood transfusion

Interventions

blood transfusionOTHER

application of single units of red blood cell transfusions

liberal transfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 9534644BACKGROUND

  • 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.

    PMID: 9824074BACKGROUND

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Dieter Köhler, Prof

    FKKG

    STUDY CHAIR

  • Dominic Dellweg, M.D.

    FKKG

    PRINCIPAL INVESTIGATOR

  • Thomas Barchfeld, M.D.

    FKKG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dieter Köhler, Prof

CONTACT

+49 2972d.koehler@fkkg.de

Dominic Dellweg, M.D.

CONTACT

+49 2972d.dellweg@fkkg.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 8, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

DE(1)