Coronary Artery Bypass Graft Triple VesselNCT00516126
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery
An observational study of Coronary Artery Bypass Graft Triple Vessel and Blood Coagulation Disorders, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Triple Vessel, Blood Coagulation Disorders
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery
Who may be able to join
- written consent
Who cannot join
- no written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors
Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).
- Keywords
- hemostasis monitoring, perioperative blood loss
- Medical subject headings
- Blood Coagulation Disorders
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 |
|---|---|---|
| Point-of-Care managed | This arm includes all patients in which the hemostatic therapy is guided by POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry) | |
| Conventional hemostasis lab managed | This arm includes all patients in which the hemostatic therapy is guided by conventional hemostasis laboratory data e.g. INR, aPTT, fibrinogen concentration, platelet count but no POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss
Measured: 24 hours
Secondary outcomes (1)
perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma
Measured: 24 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft Triple VesselStudies 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
- Prospective
- 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
- Miodrag Filipovic, PhD, MD, Study director, Department of Anesthesia, University Hospital Basel, CH-4031 Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516126
- Sponsor's protocol ID
- 194/06
- Status last verified
- Jan 2013
- First submitted
- 13 Aug 2007
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors
- ClinicalTrials.gov ID
- NCT00516126
- Acronym / sponsor ID
- 194/06
- Keywords
- hemostasis monitoring, perioperative blood loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Aug 2007 (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.
Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-Care managed | – | –This arm includes all patients in which the hemostatic therapy is guided by POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry) |
| Conventional hemostasis lab managed | – | –This arm includes all patients in which the hemostatic therapy is guided by conventional hemostasis laboratory data e.g. INR, aPTT, fibrinogen concentration, platelet count but no POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery
Key inclusion criteria (1 listed)
- written consent
Key exclusion criteria (1 listed)
- no written consent
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
Perioperative blood loss
Time frame: 24 hours
1 secondary outcome
perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma
Time frame: 24 hours and 7 days
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 11 Jan 2013.
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.
Miodrag Filipovic, PhD, MD study director
Department of Anesthesia, University Hospital Basel, CH-4031 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 Coronary Artery Bypass Graft Triple Vessel and Blood Coagulation Disorders, 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 11 Jan 2013. 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?
Perioperative blood loss (time frame: 24 hours). 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 11 Jan 2013.