Pediatric HDNCT03702192
EXCOR® Pediatric VAD Anticoagulation IDE
A study testing novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR in people with Pediatric HD, run by David N. Rosenthal.
Trial summary
The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge to transplantation for children in 2011. Successful bridge to transplantation or recovery in the IDE trial of the Berlin Heart EXCOR was 88% to 92%, but a high incidence of neurological injury was reported in this trial (29%). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric HD
- What is being tested?
- novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to 17 Jan 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Severe heart failure (NYHA functional class IV, or Ross functional class IV if < age 6 years of age), refractory to optimal medical therapy
- Patient deemed to be candidate for EXCOR implantation according to the clinical criteria employed by treating site
- Listed or eligible for cardiac transplantation according to the criteria employed by the treating site
- Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease, or acquired heart disease
- Age 0 to 18 years of age
- Corrected gestational age ≥ 37 weeks
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- Weight ≥ 3 kg and ≤ 60 kg
- Legal guardian (and patient if age-appropriate) understands the nature of the investigation, is willing to comply with the protocol and associated evaluations, and provides written informed consent and assent prior to the procedure.
- -
Who cannot join
- Support on ECMO for ≥10 days
- Cardiopulmonary resuscitation (CPR) duration ≥ 30 minutes within 48 hours prior to device implantation
- Body weight < 3.0 kg or BSA > 1.5 m2
- Presence of mechanical aortic valve
- Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy.
- Evidence of intrinsic hepatic disease as defined by a total bilirubin level or ALT greater than 5 times the upper limit of normal for age, except in association with acute heart failure as determined by the site principal investigator
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- Evidence of intrinsic renal disease as defined by a serum creatinine greater than 3 times the upper limit of normal for age, except in association with acute heart failure as determined by the investigator
- Hemodialysis or peritoneal dialysis (not including dialysis or continuous veno-venous hemofiltration (CVVH) for volume removal)
- Evidence of intrinsic pulmonary disease (eg chronic lung disease, or ARDS) as defined by need for positive pressure ventilation, except in association with acute heart failure as determined by the principal investigator
- Moderate or severe aortic and/or pulmonary valve insufficiency considered technically challenging to repair at the time of the device implantation as determined by the principal investigator
- Apical VSD or other hemodynamically-significant lesion considered technically challenging to repair at the time of device implantation as determined by the principal investigator
- Documented heparin induced thrombocytopenia (HIT) or idiopathic thrombocytopenia purpura (ITP) or other contraindication to anticoagulant/antiplatelet therapy
- Documented coagulopathy (e.g. Factor VIII deficiency, disseminated intravascular coagulation) or thrombophilic disorder (e.g. Factor V Leiden mutation)
- Hematologic disorder causing fragility of blood cells or hemolysis (e.g. sickle cell disease)
- Platelets < 70,000/ml within 24 hours prior to device implantation
- Active infection within 48 hours of implant (positive blood culture OR temperature > 38 degrees C AND wbc > 15,000/ml)
- Documented human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
- Evidence of recent or life-limiting malignant disease
- Stroke within past 30 days prior to enrollment, or congenital CNS malformation syndrome associated with increased risk of bleeding (e.g. arteriovenous malformation, moya moya)
- Psychiatric or behavioral disease (e.g. antisocial disorder) with a high likelihood for non-adherence to the protocol and follow-up
- Currently participating in another investigational device or drug trial and has not completed the required follow-up period for that study. EXCEPTION: Dual enrollment in PUMPKIN study is permitted.
- Patient is pregnant or nursing
- -
About this study
Official title: EXCOR® Pediatric VAD Anticoagulation IDE Investigational Plan
The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge to transplantation for children in 2011. Successful bridge to transplantation or recovery in the IDE trial of the Berlin Heart EXCOR was 88% to 92%, but a high incidence of neurological injury was reported in this trial (29%).
Stroke remains the most important complication of Berlin Heart EXCOR support, with high mortality rates, and considerable long-term morbidity. The EXCOR IDE study incorporated a novel anticoagulation protocol (henceforth referred to as the Edmonton Anticoagulation Protocol). The preponderance of ischemic strokes in this study raised the question of whether the anticoagulation protocol was sufficiently intensive, as ischemic strokes in this setting are virtually always thromboembolic phenomena. In response to these data and to the experience at the investigator's institution, a novel anticoagulation protocol has been devised for use with the EXCOR (Stanford anticoagulation protocol).The purpose of this study is to perform a pilot evaluation of this protocol in a multi--center setting, to prepare for a randomized trial between this and a subsequent iteration of anticoagulation treatment.
- Conditions
- Pediatric HD
- Being tested
- novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR
- Keywords
- heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel anticoagulation protocol used in conjunction with the Berlin Heart EXCORDevice
novel antithrombotic management protocol
| Study group | Role | What they receive |
|---|---|---|
| single-arm novel anticoagulation | Experimental | Single-arm clinical study to assess the safety, and effectiveness of a novel anticoagulation protocol to be used in conjunction with the Berlin Heart EXCOR Pediatric Ventricular Assist Device as a bridge to heart transplantation in children with severe heart failure who have failed optimal medical therapy. Receives: Device: novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major bleeding adverse events reported using the Stanford Anti-Thrombotic Protocol.
To test the safety of the Stanford Anti-Thrombotic Protocol.
Measured: Up to 90 days
Number of all forms of stroke events reported using the Stanford Anti-Thrombotic Protocol.
To test the effectiveness of the Stanford Anti-Thrombotic protocol.
Measured: Up 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completion17 Jan 2019
Why it stopped: PI withdrew protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric HDStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- David N. Rosenthal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David N. Rosenthal, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702192
- Sponsor's protocol ID
- IRB-47736
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2018
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCOR® Pediatric VAD Anticoagulation IDE Investigational Plan
- ClinicalTrials.gov ID
- NCT03702192
- Acronym / sponsor ID
- IRB-47736
- Conditions
- Pediatric HD
- Keywords
- heart failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI withdrew protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- David N. RosenthalUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 10 Oct 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.
The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge to transplantation for children in 2011. Successful bridge to transplantation or recovery in the IDE trial of the Berlin Heart EXCOR was 88% to 92%, but a high incidence of neurological injury was reported in this trial (29%).
Stroke remains the most important complication of Berlin Heart EXCOR support, with high mortality rates, and considerable long-term morbidity. The EXCOR IDE study incorporated a novel anticoagulation protocol (henceforth referred to as the Edmonton Anticoagulation Protocol). The preponderance of ischemic strokes in this study raised the question of whether the anticoagulation protocol was sufficiently intensive, as ischemic strokes in this setting are virtually always thromboembolic phenomena. In response to these data and to the experience at the investigator's institution, a novel anticoagulation protocol has been devised for use with the EXCOR (Stanford anticoagulation protocol).The purpose of this study is to perform a pilot evaluation of this protocol in a multi--center setting, to prepare for a randomized trial between this and a subsequent iteration of anticoagulation treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm novel anticoagulation | Experimental | Device: novel anticoagulation protocol used in conjunction with the Berlin Heart EXCORSingle-arm clinical study to assess the safety, and effectiveness of a novel anticoagulation protocol to be used in conjunction with the Berlin Heart EXCOR Pediatric Ventricular Assist Device as a bridge to heart transplantation in children with severe heart failure who have failed optimal medical therapy. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Severe heart failure (NYHA functional class IV, or Ross functional class IV if < age 6 years of age), refractory to optimal medical therapy
- Patient deemed to be candidate for EXCOR implantation according to the clinical criteria employed by treating site
- Listed or eligible for cardiac transplantation according to the criteria employed by the treating site
- Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease, or acquired heart disease
- Age 0 to 18 years of age
Key exclusion criteria (23 listed)
- Support on ECMO for ≥10 days
- Cardiopulmonary resuscitation (CPR) duration ≥ 30 minutes within 48 hours prior to device implantation
- Body weight < 3.0 kg or BSA > 1.5 m2
- Presence of mechanical aortic valve
- Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy.
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 |
|---|---|---|
| novel anticoagulation protocol used in conjunction with the Berlin Heart EXCORnovel antithrombotic management protocol | Device | single-arm novel anticoagulation |
Primary outcome
Number of major bleeding adverse events reported using the Stanford Anti-Thrombotic Protocol.
Time frame: Up to 90 days
To test the safety of the Stanford Anti-Thrombotic Protocol.
Number of all forms of stroke events reported using the Stanford Anti-Thrombotic Protocol.
Time frame: Up 90 days
To test the effectiveness of the Stanford Anti-Thrombotic protocol.
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 31 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR in people with Pediatric HD, run by David N. Rosenthal.
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 9 inclusion and 23 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 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of major bleeding adverse events reported using the Stanford Anti-Thrombotic Protocol. (time frame: Up to 90 days). The study lists 2 primary outcomes in all. 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 31 Oct 2019.