Cardiac SurgeryROTEMNCT00772239
Perioperative Coagulation Management in Cardiac Surgery.
A study testing Rotation thromboelastometry (ROTEM) and Standard coagulation managment procedure in people with Cardiac Surgery and Bleeding, run by University Hospital, Limoges at 4 sites in France.
Trial summary
Cardiac surgery is bleeding requiring transfusion surgery . The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Bleeding
- What is being tested?
- Rotation thromboelastometry (ROTEM) and Standard coagulation managment procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2008to Aug 2010
- Phase
- Interventional
- 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
Who may be able to join
- Adults> 18 years
- Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology
- given informed consent
Who cannot join
- Patient supported by a pre or postoperative circulatory technical assistance
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
Bordeaux, 33000
Service d'Anesthésie réanimation Chirurgicale
Bordeaux, 33000
Service Anésthésie
Limoges, Limoges, 87000
Service d'Anesthésie
Limoges, Limoges, 87000
About this study
Official title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
Cardiac surgery is bleeding requiring transfusion surgery .
The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.
Read more
All these changes contribute to increase the need for transfusions during heart surgery.
The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.
100 pateinst (50 in each arm) should be included in this trial.
- Conditions
- Cardiac Surgery, Bleeding
- Being tested
- Rotation thromboelastometry (ROTEM), Standard coagulation managment procedure
- Keywords
- Coagulation Management, Cardiac surgery, Bleeding, Rotem
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotation thromboelastometry (ROTEM)Device
Coagulation measurement
Standard coagulation managment procedureProcedure or surgery
Standard coagulation managment procedure
| Study group | Role | What they receive |
|---|---|---|
| Rotem | Experimental | ROTEM: Rotation thromboelastometry Receives: Device: Rotation thromboelastometry (ROTEM) |
| S | Active comparator | Standard coagulation managment procedure Receives: Procedure: Standard coagulation managment procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of different blood transfusion
Measured: during cardiac surgery management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies
- Investigators
- Nathalie NATHAN-DENIZOT, MD, Study chair, CHU limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772239
- Sponsor's protocol ID
- I07018/ROTEM CTV
- Acronym
- ROTEM
- Status last verified
- Apr 2011
- First submitted
- 13 Oct 2008
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
- ClinicalTrials.gov ID
- NCT00772239
- Acronym / sponsor ID
- ROTEM / I07018/ROTEM CTV
- Conditions
- Cardiac Surgery, Bleeding
- Keywords
- Coagulation Management, Cardiac surgery, Bleeding, Rotem
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies
- Study start
- Oct 2008
- Primary completion
- Aug 2010 (actual)
- First posted
- 15 Oct 2008 (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 is bleeding requiring transfusion surgery .
The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.
All these changes contribute to increase the need for transfusions during heart surgery.
The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.
100 pateinst (50 in each arm) should be included in this trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotem | Experimental | Device: Rotation thromboelastometry (ROTEM)ROTEM: Rotation thromboelastometry |
| S | Active comparator | Procedure: Standard coagulation managment procedureStandard coagulation managment procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults> 18 years
- Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology
- given informed consent
Key exclusion criteria (1 listed)
- Patient supported by a pre or postoperative circulatory technical assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotation thromboelastometry (ROTEM)Coagulation measurement | Device | Rotem |
| Standard coagulation managment procedureStandard coagulation managment procedure | Procedure or surgery | S |
Primary outcome
Quantity of different blood transfusion
Time frame: during cardiac surgery management
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
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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.
Nathalie NATHAN-DENIZOT, MD study chair
CHU limoges
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotation thromboelastometry (ROTEM) and Standard coagulation managment procedure in people with Cardiac Surgery and Bleeding, run by University Hospital, Limoges at 4 sites in France.
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 3 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: stopped early, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 was stopped early. Results are not available in the source record.
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?
Quantity of different blood transfusion (time frame: during cardiac surgery management). 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 26 Apr 2011.