BleedingNCT01468597
Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery
An observational study of 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 emergent cardiac surgery during dual antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Bleeding
- How many people
- 167 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients needing emergent cardiac surgery under dual antiplatelet therapy
Who may be able to join
- First time on-pump CABG with or without valve replacement
Who cannot join
- Redo surgery,
- Renal insufficiency needing dialysis,
- Concomitant medication with warfarin,
- Preoperative fibrinogen < 150 mg%
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz
Graz, 8036
About this study
Official title: Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.
Read the detailed description
Blood for measuring platelet function is drawn before induction of anesthesia
- Conditions
- Bleeding
- Keywords
- Emergent, Cardiac surgery, On-pump, Platelet function
- Medical subject headings
- 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 |
|---|---|---|
| One group | Emergency surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated Blood Loss
Measured: until postoperative day 5
Secondary outcomes (1)
BARC Bleeding
Intracranial bleed within 48 hours, Reoperation after closure of sternotomy for the purpose of controlling bleeding, Transfusion of equal to or more than 5 Units of packed red blood cells within a 48-hour period, Chest tube output of equal to or more than 2 L within a 24-h period.
Measured: until postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Mahla, M.D., Principal investigator, Department of Anesthesia and Intensive Care Medicine, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468597
- Sponsor's protocol ID
- 21-202 ex 09/10
- Status last verified
- Jun 2020
- First submitted
- 4 Oct 2011
- Last updated
- 18 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mahla E, Prueller F, Farzi S, Pregartner G, Raggam RB, Beran E, Toller W, Berghold A, Tantry US, Gurbel PA. Does Platelet Reactivity Predict Bleeding in Patients Needing Urgent Coronary Artery Bypass Grafting During Dual Antiplatelet Therapy? Ann Thorac Surg. 2016 Dec;102(6):2010-2017. doi: 10.1016/j.athoracsur.2016.05.003. Epub 2016 Jul 1.
PubMed 27378554
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. 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 Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study
- ClinicalTrials.gov ID
- NCT01468597
- Acronym / sponsor ID
- 21-202 ex 09/10
- Conditions
- Bleeding
- Keywords
- Emergent, Cardiac surgery, On-pump, Platelet function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Posted 18 Jun 2020
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 emergent cardiac surgery during dual antiplatelet therapy.
Detailed description
Blood for measuring platelet function is drawn before induction of anesthesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | – | –Emergency surgery |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients needing emergent cardiac surgery under dual antiplatelet therapy
Key inclusion criteria (1 listed)
- First time on-pump CABG with or without valve replacement
Key exclusion criteria (4 listed)
- Redo surgery,
- Renal insufficiency needing dialysis,
- Concomitant medication with warfarin,
- Preoperative fibrinogen < 150 mg%
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
Calculated Blood Loss
Time frame: until postoperative day 5
1 secondary outcome
BARC Bleeding
Time frame: until postoperative day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27378554Mahla E, Prueller F, Farzi S, Pregartner G, Raggam RB, Beran E, Toller W, Berghold A, Tantry US, Gurbel PA. Does Platelet Reactivity Predict Bleeding in Patients Needing Urgent Coronary Artery Bypass Grafting During Dual Antiplatelet Therapy? Ann Thorac Surg. 2016 Dec;102(6):2010-2017. doi: 10.1016/j.athoracsur.2016.05.003. Epub 2016 Jul 1.
Related trials for Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Elisabeth Mahla, M.D. principal investigator
Department of Anesthesia and Intensive Care Medicine, 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 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 1 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 18 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calculated Blood Loss (time frame: until postoperative day 5). 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 NCT01468597, 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 18 Jun 2020.