CPBPhase 4NCT00151853
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
A Phase 4 study testing PPSB-SD in people with CPB and Oral Anticoagulant Therapy, run by Prothya Biosolutions at 1 site in Belgium.
Trial summary
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- CPB, Oral Anticoagulant Therapy
- What is being tested?
- PPSB-SD
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2002to Sep 2004
- Phase
- Phase 4
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age at least 18 years and due to undergo (semi-) acute cardiac surgery with a relatively stable haemodynamic condition.
- and body weight less than 100 kg and informed consent and patients well controlled with acenocoumarol, phenprocoumon or warfarin.
- -
Who cannot join
- patients with an overdose of acenocoumarol, phenprocoumon or warfarin (INR > 7.8) and due to undergo (semi-) acute cardiac surgery hepatic insufficiency renal insufficiency anaphylactic reaction after administration of a blood product in the past disseminated intravascular coagulation (DIC) active thrombosis/pulmonary embolism intracardial thrombus patients treated with platelet inhibitors, except for aspirin (acetylsalicylic acid), who will be treated with aprotinine pregnancy breast-feeding
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study on the Efficacy of PPSB-SD and VP-VI in Patients Using Oral Anticoagulant Therapy and Undergoing Acute Cardiac Surgery With a Cardiopulmonary Bypass
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).
Read the detailed description
The value of oral anticoagulants such as coumarin derivatives as a therapy and in the prophylaxis of thrombosis is universally acknowledged. These medicinal products are used in the prevention of cerebral infarction, in patients with atrial fibrillation and in the secondary prevention of myocardial infarction. In case of elected surgery, the effect of coumarin derivatives can be reversed by a termination of the coumarin treatment and the administration of vitamin K orally, i.m. or i.v., which will restore the production of the vitamin K dependent coagulation factors. For patients due to undergo acute surgery, it will be unfavourable to await endogenous production of vitamin K dependent coagulation factor production.After CPB surgery, the patients need to be in a controlled coagulated state. Two products suitable to rapidly increase the concentration of vitamin K dependent coagulation factors, are fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC). These products contain factor II, VII, IX and X and help to restore normal levels of the clotting fraction.Administration of these products prior to CPB surgery will decrease the INR to a level that is acceptable for surgery. In the Academic Hospital Leuven the standard procedure in cases of acute and elected CPB surgery is administration of VP-VI, a FFP-product made by OCTAPHARMA. In this study the standard treatment of 2x 400 ml VP-VI was compared with a treatment of PPSB Solvent Detergent® (PPSB-SD) according to the prescription regimen of CAF-DCF. PPSB-SD is a PCC product made by Sanquin Plasma Products (the Netherlands) for CAF-DCF (Belgium). The regimen as prescribed by CAF-DCF enables to calculate the quantity of PPSB-SD to administer on the basis of the patient's weight, the initial INR and the target INR. The expected outcome of the study was that in patients receiving PPSB-SD the target INR will be reached more frequently and more rapidly compared to patients receiving VP-VI.
- Conditions
- CPB, Oral Anticoagulant Therapy
- Being tested
- PPSB-SD
- Keywords
- CPB, oral anticoagulant therapy, plasma, PCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPSB-SDDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to determine the mean time, median time and difference in time needed to reach the target INR of ≤1.5 after the end of CPB.
Secondary outcomes (1)
The secondary objective of this study was to compare the number of post-(cpb)operative bleedings or re-operations for bleedings as well as the difference in the need of blood transfusions between the two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMar 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPBStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P FW Strengers, MD, Study director, Prothya Biosolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151853
- Sponsor's protocol ID
- CAF2001.01
- Status last verified
- Jan 2006
- First submitted
- 8 Sep 2005
- Last updated
- 7 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study on the Efficacy of PPSB-SD and VP-VI in Patients Using Oral Anticoagulant Therapy and Undergoing Acute Cardiac Surgery With a Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00151853
- Acronym / sponsor ID
- CAF2001.01
- Conditions
- CPB, Oral Anticoagulant Therapy
- Keywords
- CPB, oral anticoagulant therapy, plasma, PCC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Sep 2004
- First posted
- 9 Sep 2005 (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 was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).
Detailed description
The value of oral anticoagulants such as coumarin derivatives as a therapy and in the prophylaxis of thrombosis is universally acknowledged. These medicinal products are used in the prevention of cerebral infarction, in patients with atrial fibrillation and in the secondary prevention of myocardial infarction. In case of elected surgery, the effect of coumarin derivatives can be reversed by a termination of the coumarin treatment and the administration of vitamin K orally, i.m. or i.v., which will restore the production of the vitamin K dependent coagulation factors. For patients due to undergo acute surgery, it will be unfavourable to await endogenous production of vitamin K dependent coagulation factor production.After CPB surgery, the patients need to be in a controlled coagulated state. Two products suitable to rapidly increase the concentration of vitamin K dependent coagulation factors, are fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC). These products contain factor II, VII, IX and X and help to restore normal levels of the clotting fraction.Administration of these products prior to CPB surgery will decrease the INR to a level that is acceptable for surgery. In the Academic Hospital Leuven the standard procedure in cases of acute and elected CPB surgery is administration of VP-VI, a FFP-product made by OCTAPHARMA. In this study the standard treatment of 2x 400 ml VP-VI was compared with a treatment of PPSB Solvent Detergent® (PPSB-SD) according to the prescription regimen of CAF-DCF. PPSB-SD is a PCC product made by Sanquin Plasma Products (the Netherlands) for CAF-DCF (Belgium). The regimen as prescribed by CAF-DCF enables to calculate the quantity of PPSB-SD to administer on the basis of the patient's weight, the initial INR and the target INR. The expected outcome of the study was that in patients receiving PPSB-SD the target INR will be reached more frequently and more rapidly compared to patients receiving VP-VI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age at least 18 years and due to undergo (semi-) acute cardiac surgery with a relatively stable haemodynamic condition.
- and body weight less than 100 kg and informed consent and patients well controlled with acenocoumarol, phenprocoumon or warfarin.
- -
Key exclusion criteria (2 listed)
- patients with an overdose of acenocoumarol, phenprocoumon or warfarin (INR > 7.8) and due to undergo (semi-) acute cardiac surgery hepatic insufficiency renal insufficiency anaphylactic reaction after administration of a blood product in the past disseminated intravascular coagulation (DIC) active thrombosis/pulmonary embolism intracardial thrombus patients treated with platelet inhibitors, except for aspirin (acetylsalicylic acid), who will be treated with aprotinine pregnancy breast-feeding
- -
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 |
|---|---|---|
| PPSB-SD | Drug | – |
Primary outcome
The primary objective of this study was to determine the mean time, median time and difference in time needed to reach the target INR of ≤1.5 after the end of CPB.
1 secondary outcome
The secondary objective of this study was to compare the number of post-(cpb)operative bleedings or re-operations for bleedings as well as the difference in the need of blood transfusions between the two groups
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 7 Dec 2023.
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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.
P FW Strengers, MD study director
Prothya Biosolutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PPSB-SD in people with CPB and Oral Anticoagulant Therapy, run by Prothya Biosolutions at 1 site in Belgium.
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 3 inclusion and 2 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 7 Dec 2023. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study was to determine the mean time, median time and difference in time needed to reach the target INR of ≤1.5 after the end of CPB.. 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 7 Dec 2023.