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Immunological Responses in Bovine vs Mechanical Composite Grafts (IRBOcomp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010396
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

In the first retrospective part of the study the investigators will conduct a data analysis of patients having received a bovine aortic graft. The investigators will analyze charts and CT / MRI at various time intervals and identify if there are signs of inflammation.

In the second prospective part the investigators will select survivors from the first part with and without inflammation signs. If they consent to participate in the study the investigators will do a blood sampling in order to perform further immunological analysis. Additionally, the investigators will examine their quality of life by QoL SF-12 questionnaire.


Condition or disease Intervention/treatment
Immune Defect Other: Blood sampling

Detailed Description:

Part 1 Retrospective database search on subjects that received a Shelhigh graft (n= 116) and subjects that received a mechanical graft (n=50) in a similar time frame, age, gender, co-morbidities, clinical history.

Analyzing CT or MRI report at following time intervals: 3 - 6 months postoperatively, 1, 2 and 3 years postoperatively (regular check-up appointments in clinics).

Additionally, extraction of following data-set (based on availability): temperature, lab values (C-reactive protein, white blood count, Eosinophil count), pathology report and CT- / MRI- imaging in cases of re-operation.

Firstly, identify if there is a graft inflammation (positive / negative group within the bovine group).

Secondly, compare to mechanical group.

Part 2 Choose 10 + 10 patients of the bovine group (with / without immune response) and 10 of the mechanical group in order to conduct further immunological testing and comparison. The immunological testing will include measurement of immunoglobulin E and immunoglobulin G antibodies against bovine protein, as well as in vitro T cell reactivity in Interleukin 4 and interferon-gamma Elispot. These parameters will characterize whether the patient mounted an adaptive immune response against the bovine protein. In addition, the investigators will measure total immunoglobulin G4 and Interleukin-6 levels in the serum of all patients, as additional inflammation markers.

Contact patients to come into clinics for a visit, explain study. Blood sampling (1 serum and 1 EDTA) after patients consent.

Material will be sampled and sent in anonymized form via express courier to the Translational Immunology Lab at the University Hospital Basel. Samples will be processed within 24h to isolate peripheral blood mononuclear cells (PBMC) and serum. PBMC and Serum will be cryopreserved at -180°C and -80°C respectively. Samples will be analyzed in batches each including 3-5 subjects per group.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Official Title: Clinical and Immunological Patterns of Non-infectious Aortic Graft Inflammation in Bovine vs Non-biological Grafts
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Group/Cohort Intervention/treatment
Recipients of Bovine Graft
Recruitment and informed consent procedure for blood sampling to conduct immunological testing. In addition a questionnaire on QOL (SF-12) will be used to evaluate the most actual quality of life of these patients.
Other: Blood sampling
Blood sampling: 1 EDTA and 1 Serum vial

Recipients of Mechanical Graft
Recruitment and informed consent procedure for blood sampling to conduct immunological testing. In addition a questionnaire on QOL (SF-12) will be used to evaluate the most actual quality of life of these patients.
Other: Blood sampling
Blood sampling: 1 EDTA and 1 Serum vial




Primary Outcome Measures :
  1. Inflammatory Response [ Time Frame: postoperatively, up to 30 years ]
    Percentage of patients having received the bovine conduit graft showing a graft inflammation.


Secondary Outcome Measures :
  1. Inflammatory Response in Control Group [ Time Frame: postoperatively, up to 30 years ]
    Comparison of the bovine group to patients having received a mechanical composite graft.


Biospecimen Retention:   Samples With DNA
Blood Samples (1 EDTA + 1 Serum vial)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Part 1: n=116 bovine (total amount of recipients of the Shelhigh graft at the investigators' institution).

50 (mechanical control)

Part 2: n= 10 (bovine with immune response) +10 (bovine without immune response) +10 (mechanical control)

Criteria

Inclusion Criteria:

  • Recipients of the bovine graft or mechanical graft. For the prospective part 2: able to give informed consent by signature, age, matching characteristics and time frame.

Exclusion Criteria:

  • Individuals of the patient cohort from the last 20 years who indicated that their data cannot be utilized for future research will be excluded from the study.
  • Inability or any contraindications to undergo the planned investigated intervention, clinically significant concomitant diseases precluding ambulatory control in the day clinic in Bern.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010396


Locations
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Switzerland
University Hospital Bern, Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: ThierryThierry Prof. Dr. med. Carrel Departmnet Chair
Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04010396    
Other Study ID Numbers: 24.06.2019 V 1.0
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No