BleedingPACENCT01218074
Platelets Antiaggregation Control Enhancement (PACE) Study
A study testing Aggregometry+Thromboelastography and Thromboelastography Alone in people with Bleeding and Blood Transfusion, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bleeding, Blood Transfusion
- What is being tested?
- Aggregometry+Thromboelastography and Thromboelastography Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2010to Sep 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing surgical myocardial revascularization.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study
Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.
- Conditions
- Bleeding, Blood Transfusion
- Being tested
- Aggregometry+Thromboelastography, Thromboelastography Alone
- Keywords
- bleeding, blood sparing procedure, desmopressin, aggregometry, thromboelastography
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggregometry+ThromboelastographyDevice
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Thromboelastography AloneDevice
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
| Study group | Role | What they receive |
|---|---|---|
| Thromboelastography alone | Active comparator | Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances. Receives: Device: Thromboelastography Alone |
| Aggregometry+Tromboelastography | Experimental | Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin. Receives: Device: Aggregometry+Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Volume
Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.
Measured: 12 hours after end of operation
Secondary outcomes (1)
Use of allogenic blood transfusions.
Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.
Measured: In hospital stay (usually 5 to 8 days after operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Weltert, Cardiochirurgia E.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218074
- Sponsor's protocol ID
- 00-04
- Acronym
- PACE
- Status last verified
- Jan 2018
- First submitted
- 5 Oct 2010
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study
- ClinicalTrials.gov ID
- NCT01218074
- Acronym / sponsor ID
- PACE / 00-04
- Conditions
- Bleeding, Blood Transfusion
- Keywords
- bleeding, blood sparing procedure, desmopressin, aggregometry, thromboelastography
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Oct 2010 (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.
Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thromboelastography alone | Active comparator | Device: Thromboelastography AlonePatients undergo standard of care Thromboelastography to evaluate overall coagulation performances. |
| Aggregometry+Tromboelastography | Experimental | Device: Aggregometry+ThromboelastographyPatients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing surgical myocardial revascularization.
Key exclusion criteria (1 listed)
- none.
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 |
|---|---|---|
| Aggregometry+ThromboelastographyPatients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin. | Device | Aggregometry+Tromboelastography |
| Thromboelastography AlonePatients undergo standard of care Thromboelastography to evaluate overall coagulation performance. | Device | Thromboelastography alone |
Primary outcome
Bleeding Volume
Time frame: 12 hours after end of operation
Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.
1 secondary outcome
Use of allogenic blood transfusions.
Time frame: In hospital stay (usually 5 to 8 days after operation)
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 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aggregometry+Thromboelastography and Thromboelastography Alone in people with Bleeding and Blood Transfusion, run by Cardiochirurgia E.H. at 1 site in Italy.
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: stopped early, as of the sponsor's last update on 26 Jan 2018. 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 Italy. 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?
Bleeding Volume (time frame: 12 hours after end of operation). 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 Jan 2018.