Cardiac SurgeryNCT01462968
Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
A study testing Activated clotting time versus blood-heparin concentration in people with Cardiac Surgery, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to find the heparinization method, which 1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis 2. gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Activated clotting time versus blood-heparin concentration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Mar 2012
- 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
- Elective on-pump coronary artery bypass grafting (CABG) single procedure
- Elective aortavalve replacement (AVR) (single procedure)
Who cannot join
- Emergency procedures
- Children and youngsters less than 18 years
- Pregnancy
- Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)
- Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)
- Known coagulopathy
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- Endocarditis
- Preoperative anaemia
- Dialysis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
The purpose of this study is to find the heparinization method, which
- affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
- gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.
The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.
- Conditions
- Cardiac Surgery
- Being tested
- Activated clotting time versus blood-heparin concentration
- Keywords
- Heparin treatment during cardiac surgery, Heparin reversal after cardiac surgery, Thrombin generation, Endogenous Thrombin potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated clotting time versus blood-heparin concentrationDevice
Also called ACT, Hemochron Signature Elite, Hepcon, HMS
Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration
| Study group | Role | What they receive |
|---|---|---|
| Activated clotting time (ACT) group | Active comparator | heparinization measured as activated clotting time during surgery Receives: Device: Activated clotting time versus blood-heparin concentration |
| Hepcon group | Experimental | heparinization measured as heparin concentration in the blood during surgery Receives: Device: Activated clotting time versus blood-heparin concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta Thrombingeneration
Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope
Measured: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Secondary outcomes (4)
peroperative heparine/protaminesulphate ratio
Measured: The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours
Platelet function
Platelet aggregation measured by Multiplate platelet function analyzer
Measured: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Thromboelastometry
We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness
Measured: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Standard coagulationtests
Measured: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Why it stopped: The study never started due to problems with Laboratory facilities in collaborating center
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 Aalborg University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital
- Investigators
- Susanne de Neergaard, Perfusionist, Principal investigator, Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462968
- Sponsor's protocol ID
- N-20110037
- Status last verified
- Oct 2011
- First submitted
- 17 Oct 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01462968
- Acronym / sponsor ID
- N-20110037
- Conditions
- Cardiac Surgery
- Keywords
- Heparin treatment during cardiac surgery, Heparin reversal after cardiac surgery, Thrombin generation, Endogenous Thrombin potential
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started due to problems with Laboratory facilities in collaborating center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 1 Nov 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.
The purpose of this study is to find the heparinization method, which
- affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis
- gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery.
The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activated clotting time (ACT) group | Active comparator | Device: Activated clotting time versus blood-heparin concentrationheparinization measured as activated clotting time during surgery |
| Hepcon group | Experimental | Device: Activated clotting time versus blood-heparin concentrationheparinization measured as heparin concentration in the blood during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective on-pump coronary artery bypass grafting (CABG) single procedure
- Elective aortavalve replacement (AVR) (single procedure)
Key exclusion criteria (9 listed)
- Emergency procedures
- Children and youngsters less than 18 years
- Pregnancy
- Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors)
- Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc)
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 |
|---|---|---|
| Activated clotting time versus blood-heparin concentrationAlso: ACT, Hemochron Signature Elite, Hepcon, HMSActivated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration | Device | Activated clotting time (ACT) group, Hepcon group |
Primary outcome
Delta Thrombingeneration
Time frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope
4 secondary outcomes
peroperative heparine/protaminesulphate ratio
Time frame: The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours
Platelet function
Time frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Thromboelastometry
Time frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Standard coagulationtests
Time frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Susanne de Neergaard, Perfusionist principal investigator
Heart-Lung surgery unit, Aalborg Hospital, Aarhus University Hospital, Hobrovej 18-22, DK-9000 Aalborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated clotting time versus blood-heparin concentration in people with Cardiac Surgery, run by Aalborg University Hospital at 1 site in Denmark.
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 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: withdrawn, as of the sponsor's last update on 26 Jun 2015. 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 Denmark. 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 withdrawn before enrolling participants, so there are no results.
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?
Delta Thrombingeneration (time frame: Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours.). 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 Jun 2015.