Postoperative BleedingBIANCANCT01606865
Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery
An observational study of Postoperative Bleeding, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Bleeding
- How many people
- 207 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to Jan 2014
- 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 taking Clopidogrel, Prasugrel, or Ticagrelor within at least 7 days
Who may be able to join
- intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
- spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)
Who cannot join
- concomitant medication with warfarin
- renal insufficiency needing dialysis
- concomitant therapy with GPIIB/IIIA Antagonists
- expected duration of operation >30min
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesiology and Intensive Care Medicine, Medical University Graz
Graz, 8036
About this study
Official title: Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.
- Conditions
- Postoperative Bleeding
- Medical subject headings
- Postoperative 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 |
|---|---|---|
| elective and acute non-cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
increased risk of bleeding (according to TIMI definition)
Measured: 24hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startSep 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative BleedingStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helfried Metzler, MD, Medical University of Graz
- Investigators
- Helfried Metzler, Prof. Dr., Study chair, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606865
- Sponsor's protocol ID
- BIANCA
- Acronym
- BIANCA
- Status last verified
- Oct 2014
- First submitted
- 24 May 2012
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT01606865
- Acronym / sponsor ID
- BIANCA / BIANCA
- Conditions
- Postoperative Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 May 2012 (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.
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elective and acute non-cardiac surgery | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients taking Clopidogrel, Prasugrel, or Ticagrelor within at least 7 days
Key inclusion criteria (2 listed)
- intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
- spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)
Key exclusion criteria (4 listed)
- concomitant medication with warfarin
- renal insufficiency needing dialysis
- concomitant therapy with GPIIB/IIIA Antagonists
- expected duration of operation >30min
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
increased risk of bleeding (according to TIMI definition)
Time frame: 24hours postoperatively
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 23 Oct 2014.
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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.
Helfried Metzler, Prof. Dr. study chair
Medical University of Graz
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 Postoperative Bleeding, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 4 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 23 Oct 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 Austria. 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?
increased risk of bleeding (according to TIMI definition) (time frame: 24hours postoperatively). 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 23 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.