AnticoagulationPhase 4KVADNCT03473132
Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
A Phase 4 study testing four factor prothrombin complex concentrate in people with Anticoagulation and Anticoagulation Reversal, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anticoagulation, Anticoagulation Reversal
- What is being tested?
- four factor prothrombin complex concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 31 Mar 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVAD on warfarin requiring temporary interruption of anticoagulation for procedures
Who cannot join
- recent thrombotic event
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kate Jolley, BA, 617-525-9337, kljolley@bwh.harvard.edu
Revital Freedman, PhD, 617-525-9337, rfreedman5@bwh.harvard.edu
About this study
Official title: Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).
Read the detailed description
Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..
- Conditions
- Anticoagulation, Anticoagulation Reversal
- Being tested
- four factor prothrombin complex concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
four factor prothrombin complex concentrateDrug
After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Based on starting international normalized ratio (INR) and target INR, the dose of four factor prothrombin complex concentrate will be calculated and infused. Coagulation factor levels will be assessed over 48-72 hours. Receives: Drug: four factor prothrombin complex concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio
assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC
Measured: through 48 hours
Secondary outcomes (2)
Adverse events
bleeding
Measured: 30 days
adverse events
thrombosis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start15 Mar 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study of consecutive patients.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Principal investigator, Jean M Connors, Brigham and Women's Hospital
- Investigators
- Jean M Connors, MD, Principal investigator, Brigham and Women';s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473132
- Sponsor's protocol ID
- 2017P001254
- Acronym
- KVAD
- Status last verified
- Apr 2021
- First submitted
- 7 Feb 2018
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes
Publications
Sylvester KW, Grandoni J, Rhoten M, Coakley L, Lyons-Matiello E, Frankel K, Fortin B, Jolley K, Park HS, Freedman RY, Mehra MR, Givertz MM, Connors JM. Assessment of Temporary Warfarin Reversal in Patients With Left Ventricular Assist Devices: the KVAD Study. J Card Fail. 2024 Sep;30(9):1111-1119. doi: 10.1016/j.cardfail.2024.02.022. Epub 2024 Mar 21.
PubMed 38521486
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC
- ClinicalTrials.gov ID
- NCT03473132
- Acronym / sponsor ID
- KVAD / 2017P001254
- Conditions
- Anticoagulation, Anticoagulation Reversal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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.
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).
Detailed description
Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of consecutive patients.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: four factor prothrombin complex concentrateBased on starting international normalized ratio (INR) and target INR, the dose of four factor prothrombin complex concentrate will be calculated and infused. Coagulation factor levels will be assessed over 48-72 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- LVAD on warfarin requiring temporary interruption of anticoagulation for procedures
Key exclusion criteria (1 listed)
- recent thrombotic event
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 |
|---|---|---|
| four factor prothrombin complex concentrateAfter treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined. | Drug | Treatment |
Primary outcome
plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio
Time frame: through 48 hours
assessment of change in vitamin K dependent coagulation factor levels after infusion of 4F-PCC
2 secondary outcomes
Adverse events
Time frame: 30 days
adverse events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 38521486Sylvester KW, Grandoni J, Rhoten M, Coakley L, Lyons-Matiello E, Frankel K, Fortin B, Jolley K, Park HS, Freedman RY, Mehra MR, Givertz MM, Connors JM. Assessment of Temporary Warfarin Reversal in Patients With Left Ventricular Assist Devices: the KVAD Study. J Card Fail. 2024 Sep;30(9):1111-1119. doi: 10.1016/j.cardfail.2024.02.022. Epub 2024 Mar 21.
- Individual participant dataSharing planned: Undecided. yes
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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.
Jean M Connors, MD principal investigator
Brigham and Women';s Hospital
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 four factor prothrombin complex concentrate in people with Anticoagulation and Anticoagulation Reversal, run by Brigham and Women's Hospital at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 5 May 2021. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean M Connors, MD (617-525-9337, jconnors@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentration of factors II,VII, IX, X, proteins S and C every 6 hours for 48 hours after treatment with 4F-PCC and correlation with international normalized ratio (time frame: through 48 hours). 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 NCT03473132, 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 5 May 2021.