Heart DiseaseNCT01281397
Bleeding Prediction in Patients Following Cardiac Surgery Using Whole Blood Aggregometry and Thromboelastometry
An observational study of Heart Disease and Coronary Artery Disease, run by University of Zagreb at 1 site in Croatia.
Trial summary
Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Coronary Artery Disease, Aortic Valve Disease
- How many people
- 148 participants
- Where
- 1 siteCroatia
- Study dates
- Aug 2009to Jan 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: All patients undergoing elective cardiac surgery with cardiopulmonary bypass are enrolled in study.
Who may be able to join
- > 18 years old
- Elective cardiac surgery patients
- Coronary artery disease
- Aortic valve disease
- Mitral valve disease
- Ascendent aorta aneurysm
- Combine coronary and valve disease
- Cardiac surgery procedures using cardiopulmonary bypass
Who cannot join
- Missing consent
- Patients with emergent cardiac surgical procedures
- Patients on antiplatelet therapy other than aspirin or clopidogrel
- Patients with inaccurate antiplatelet therapy administration documentation
- Missing data
- Off-pump procedures
Show all 9Show fewer
- Patients younger than 18 years old
- Patients with severe mental disorders
- Intrinsic coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry
Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery.
The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry.
Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.
- Keywords
- cardiac surgery, aggregometry, thromboelastometry, platelet function, bleeding, antiplatelet therapy
- Medical subject headings
- Heart Diseases, Coronary Artery Disease, Aortic Valve Disease, Hemorrhage
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 |
|---|---|---|
| Patients undergoing elective cardiac surgery | Patients undergoing elective cardiac surgery will be enrolled in study. Data about antiplatelet therapy ingestion prior to surgery will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube output in first 24 hours
Measured: 24 hours after surgical procedure
Secondary outcomes (1)
Allogenic blood products transfusion
Measured: 7 days after surgery including the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb, Ministry of Science, Education and Sport, Republic of Croatia
- Responsible party
- Principal investigator, Petricevic Mate, University of Zagreb
- Investigators
- Mate Petricevic, M.D., Principal investigator, University hospital center Zagreb- RebroBojan Biocina, M.D., Ph.D., Study chair, University hospital center Zagreb - Rebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281397
- Sponsor's protocol ID
- Project code: 198-1980976-097
- Status last verified
- Dec 2014
- First submitted
- 19 Jan 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Petricevic M, Biocina B, Milicic D, Svetina L, Boban M, Lekic A, Konosic S, Milosevic M, Gasparovic H. Activated coagulation time vs. intrinsically activated modified rotational thromboelastometry in assessment of hemostatic disturbances and blood loss after protamine administration in elective cardiac surgery: analysis from the clinical trial (NCT01281397). J Cardiothorac Surg. 2014 Sep 17;9:129. doi: 10.1186/1749-8090-9-129.
PubMed 25231271
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Prediction in Patients Undergoing Cardiac Surgery Using Whole Blood Impedance Aggregometry and Rotational Thromboelastometry
- ClinicalTrials.gov ID
- NCT01281397
- Acronym / sponsor ID
- Project code: 198-1980976-097
- Keywords
- cardiac surgery, aggregometry, thromboelastometry, platelet function, bleeding, antiplatelet therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb, Ministry of Science, Education and Sport, Republic of Croatia
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Jan 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.
Use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery.
The purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry.
Antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. Another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective cardiac surgery | – | –Patients undergoing elective cardiac surgery will be enrolled in study. Data about antiplatelet therapy ingestion prior to surgery will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing elective cardiac surgery with cardiopulmonary bypass are enrolled in study.
Key inclusion criteria (8 listed)
- > 18 years old
- Elective cardiac surgery patients
- Coronary artery disease
- Aortic valve disease
- Mitral valve disease
Key exclusion criteria (9 listed)
- Missing consent
- Patients with emergent cardiac surgical procedures
- Patients on antiplatelet therapy other than aspirin or clopidogrel
- Patients with inaccurate antiplatelet therapy administration documentation
- Missing data
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
Chest tube output in first 24 hours
Time frame: 24 hours after surgical procedure
1 secondary outcome
Allogenic blood products transfusion
Time frame: 7 days after surgery including the day of surgery
Results and safety
The study was stopped early (reason given: After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 25231271Petricevic M, Biocina B, Milicic D, Svetina L, Boban M, Lekic A, Konosic S, Milosevic M, Gasparovic H. Activated coagulation time vs. intrinsically activated modified rotational thromboelastometry in assessment of hemostatic disturbances and blood loss after protamine administration in elective cardiac surgery: analysis from the clinical trial (NCT01281397). J Cardiothorac Surg. 2014 Sep 17;9:129. doi: 10.1186/1749-8090-9-129.
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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.
Mate Petricevic, M.D. principal investigator
University hospital center Zagreb- Rebro
Bojan Biocina, M.D., Ph.D. study chair
University hospital center Zagreb - Rebro
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 Heart Disease and Coronary Artery Disease, run by University of Zagreb at 1 site in Croatia.
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 8 inclusion and 9 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 3 Dec 2014. 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 Croatia. 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 (reason given: After 148 patients enrolled, interim analysis revealed positive results in regard to primary hypothesis.). 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?
Chest tube output in first 24 hours (time frame: 24 hours after surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281397, which also lists 1 linked publication.
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 3 Dec 2014.