Cardiac ArrestNCT01446354
Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery
An observational study of Cardiac Arrest, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest
Who may be able to join
- Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Anesthesia and Intensive Care Medicine
Basel, Canton of Basel-City, 4031
About this study
Official title: Does the Intraoperative Thromboelastometry-guided Coagulation Management Reduce the Administration of Allogeneic Blood Products in Cardiac Surgery With the Help of Hypothermic Cardiac Arrest? A Retrospective Data Analysis
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.
- Conditions
- Cardiac Arrest
- Keywords
- Blood component transfusion, Hypothermic
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery with HCA | Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion of allogeneic blood products
Measured: within 24 hours including surgery
Secondary outcomes (2)
Proportion of patients without allogeneic blood products
Measured: 24 hours including surgery
Adverse events
Adverse events include: renal impairment (RIFLE criteria), stroke, severe neurologic impairment, myocardial infarction, death, re-exploration
Measured: within 24 hours including surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bolliger, University Hospital, Basel, Switzerland
- Investigators
- Daniel Bolliger, PD Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446354
- Sponsor's protocol ID
- 347/10
- Status last verified
- Oct 2012
- First submitted
- 29 Sep 2011
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Intraoperative Thromboelastometry-guided Coagulation Management Reduce the Administration of Allogeneic Blood Products in Cardiac Surgery With the Help of Hypothermic Cardiac Arrest? A Retrospective Data Analysis
- ClinicalTrials.gov ID
- NCT01446354
- Acronym / sponsor ID
- 347/10
- Conditions
- Cardiac Arrest
- Keywords
- Blood component transfusion, Hypothermic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery with HCA | – | –Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest
Key inclusion criteria (1 listed)
- Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transfusion of allogeneic blood products
Time frame: within 24 hours including surgery
2 secondary outcomes
Proportion of patients without allogeneic blood products
Time frame: 24 hours including surgery
Adverse events
Time frame: within 24 hours including surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Bolliger, PD Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion of allogeneic blood products (time frame: within 24 hours including surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.