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CompletedNCT01446354Updated Oct 24, 2012

Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

An observational study in Cardiac Arrest, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2012-10-24.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study summary

Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line hemostatic agent on the perioperative use of allogeneic blood products.

Read the detailed description

The investigators will analyze the data of patients undergoing elective and emergent surgical procedures involving the ascendent aorta and/or the aortic arch with the help of HCA from January 2009 to June 2011.

The investigators will collect and document baseline characteristics, the use of thromboelastometry, thromboelastometric data, and perioperative laboratory data. In addition, the investigators will evaluate perioperative bleeding from mediastinal drainages, perioperative use of blood and hemostatic products, and the adverse events within the hospitalisation including re-exploration, renal impairment, myocardial infarction, severe brain injury, and death.

02

Conditions studied

  • Cardiac Arrest

Keywords

  • Blood component transfusion
  • Hypothermic
03

In context

Heart Arrest

984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 200 is close to the median of 196 across 394 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)

Groups and cohorts

  • Cardiac surgery with HCA

    Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta

06

What researchers measure

Primary outcomes

  1. Transfusion of allogeneic blood products

    Time frame: within 24 hours including surgery

Secondary outcomes

  1. Proportion of patients without allogeneic blood products

    Time frame: 24 hours including surgery

  2. Adverse events

    Adverse events include: renal impairment (RIFLE criteria), stroke, severe neurologic impairment, myocardial infarction, death, re-exploration

    Time frame: within 24 hours including surgery

07

Study locations

1 site
  • University Hospital Basel, Department of Anesthesia and Intensive Care Medicine
    Basel, Canton of Basel-City 4031, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01446354
Responsible party
Daniel Bolliger (Principal Investigator, University Hospital, Basel, Switzerland) — Principal investigator
First posted
Oct 5, 2011
Start date
Jan 2011
Primary completion
Dec 2011
Completion
Feb 2012
Last update
Oct 24, 2012

Study contacts

Daniel Bolliger, PD Dr.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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