NCT01402739

Brief Summary

Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

July 25, 2011

Last Update Submit

June 12, 2015

Conditions

Chest Tube OutputAllogeneic Blood Transfusions

Keywords

PoCROTEMMultiplatetransfusioncardiac surgerydrainage blood losschest tube output

Outcome Measures

Primary Outcomes (1)

  • chest tube output

    24 hours

Secondary Outcomes (4)

  • need of allogeneic blood transfusions

    24 hours

  • course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)

    24 hours

  • duration of mechanical ventilation

    hours (average)

  • incidence of RRT

    during 30 days

Study Arms (2)

PoC algorithm guided transfusions

EXPERIMENTAL

experimental arm

Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm

standard of care transfusions

ACTIVE COMPARATOR

control arm

Other: standard coagulation monitoring guided transfusion algorithm

Interventions

Point of Care Coagulation Monitoring Guided Transfusion AlgorithmOTHER

(thromboelastometry, aggregometry, blood gas analysis)

Also known as: ROTEM delta, Multiplate, ABL 725
PoC algorithm guided transfusions
standard coagulation monitoring guided transfusion algorithmOTHER

aPTT, ACT, platelet count, hemoglobin, fibrinogen

standard of care transfusions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective cardiac surgery patient requiring cardiopulmonary bypass
  • moderate or high transfusion risk
  • signed informed consent

You may not qualify if:

  • age \<18 or \>80 years
  • known hemophilia
  • known thrombophilia
  • known thrombocytopathy
  • hereditary or acquired coagulation disorder
  • active endocarditis
  • ejection fraction \<30%
  • BSA \< 1.8 sqm
  • planned aortic arch surgery
  • preoperative thrombocytopenia \<150/nl
  • underlying hemostaseological disease
  • preoperative anemia
  • liver cirrhosis Child B or higher
  • preoperative creatinine \> 2mg/dl
  • terminal renal insufficiency requiring dialysis
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • Lehmann F, Rau J, Malcolm B, Sander M, von Heymann C, Moormann T, Geyer T, Balzer F, Wernecke KD, Kaufner L. Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study. BMC Anesthesiol. 2019 Feb 18;19(1):24. doi: 10.1186/s12871-019-0689-7.

    PMID: 30777015DERIVED

Study Officials

  • Michael Sander, MD

    Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

  • Claudia D Spies, MD

    Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Univ.-Prof. M. Sander

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

DE(1)