Bone Marrow Aspiration for Kidney Transplant Rejection
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mark Stegall
Must not be taking: Heparin, Coumadin, others
Disqualifiers: Low platelets, Low neutrophils, Malignancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The aim of this study is to determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain blood thinners like heparin or coumadin.
What data supports the effectiveness of the treatment Bone Marrow Aspiration for Kidney Transplant Rejection?
Bone marrow aspiration is a valuable diagnostic tool for evaluating bone marrow health and detecting conditions like lymphomas and other blood disorders. While the studies focus on its diagnostic use, the ability to accurately assess bone marrow health may indirectly support its potential role in monitoring or managing kidney transplant rejection.
12345Is bone marrow aspiration generally safe for humans?
Bone marrow aspiration is generally considered safe, but it can have rare complications like bleeding, especially in patients with blood disorders or those on certain medications. Serious adverse events are uncommon, but they can occur, such as a reported case of injury to the aorta during a sternal biopsy.
16789How does bone marrow aspiration differ from other treatments for kidney transplant rejection?
Bone marrow aspiration is unique because it involves taking a sample of bone marrow (the soft tissue inside bones) to help diagnose or understand conditions, rather than directly treating kidney transplant rejection. This procedure is typically used for diagnosing blood-related conditions and is not a standard treatment for kidney transplant rejection, which usually involves medications to suppress the immune system.
12578Eligibility Criteria
This trial is for kidney transplant recipients with antibodies against their donors (sensitized) and the living donors themselves. Participants must consent to study procedures not part of normal care. Excluded are those with low neutrophil or platelet counts, recent investigational drug use, current systemic anticoagulation therapy, certain cancer histories within 5 years, or serious medical/psychiatric conditions.Inclusion Criteria
People who have donated a kidney for a transplant.
Those who give voluntary written informed consent before performance of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
I have antibodies against a kidney transplant as shown by a specific test.
Exclusion Criteria
I haven't had cancer, except for certain skin cancers or low-risk prostate cancer treated over 5 years ago.
Patient has an absolute neutrophil count of ANC<1.0 x 10(9)/L within 14 days before enrollment
I am currently on blood thinners like heparin or coumadin.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Bone Marrow Aspiration
Paired bone marrow aspirations are performed to assess the variability of Allo-ELISPOT and Allo-Specificities assays
1 day
1 visit (in-person)
Lymph Node Retrieval
Lymph node retrieval is performed for abstraction of immune cells for additional analysis
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after procedures
4 weeks
Participant Groups
The study tests the validity of two assays on bone marrow from sensitized kidney transplant recipients to understand the higher rejection risk in these patients. It involves marrow aspirations from both recipients and living donors to assess immune responses.
1Treatment groups
Experimental Treatment
Group I: Kidney recipients or kidney donorsExperimental Treatment2 Interventions
Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
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Who Is Running the Clinical Trial?
Mark StegallLead Sponsor
Mayo ClinicLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy. [2022]Bone marrow aspiration and biopsy is an invasive procedure associated with morbidity and mortality risk. We compared a powered bone marrow aspiration and biopsy device to the traditional method by relatively assessing pain scores, procedure times, biopsy capture rates, quality of material retrieved, and safety and operator satisfaction.
[Bone marrow aspiration: practical aspects]. [2006]Bone marrow aspiration is the most valuable diagnostic examination for the evaluation of hematopoiesis of the bone marrow. Appropriate smear-sampling and reliable stainings in hematological sections are essential for the precise diagnosis of bone marrow cells, and give important insight into pathological and clinical hematology.
[Value and limitations of the combined cyto-histological study of hematopoietic bone marrow. 200 cases]. [2006]Bone marrow was simultaneously obtained by aspiration and by biopsy in a series of 200 patients in order to evaluate the potential usefulness of pathological-anatomical examination (paraffin-embedding technique). Conditions studied included search for lymphomas (26.5%), multiple myelomas (24.5%) and metastases (7.5%) and the evaluation of myeloproliferative syndromes (17.5%) and other hematological disorders such as cytopenias, anemias and leukemias (24%). In 76% of the cases the two methods of evaluation were equivalent. Nevertheless, comparison of the cytological and histological methods provided a greater measure of diagnostic confidence. In 24 cases (12%) the bone biopsy was the only diagnostic procedure; these comprised partly dry aspirations and partly bone marrow smears in which the specific lesion was not represented. Bone marrow aspiration proved superior in 24 cases (12%) in view of the better detection of small and discrete malignant infiltrates and more detailed analysis of blasts and cytological changes in cell maturation. On the basis of the techniques employed in this series of 200 patients, a combination of the two investigations appears to be indispensable for the evaluation of lymphoand myeloproliferative syndromes, of cytopenias with or without fever of unknown origin, and in the search for metastatic disease.
Complications associated with improper palpation-guided iliac bone marrow biopsy tracts identified on follow-up imaging. [2022]Bone marrow biopsy complications are rare. Our aim is to study the association of improper palpation-guided iliac biopsy tract with complications.
Accuracy and relative value of bone marrow aspiration in the detection of lymphoid infiltration in non-Hodgkin lymphoma. [2022]In hematologic malignancies, bone marrow aspiration is considered complementary to bone marrow biopsy for the detection of tumor infiltration. The present study evaluated the accuracy of bone marrow aspiration and the relative contributions of bone marrow aspiration and bone marrow biopsy in detecting bone marrow involvement by non-Hodgkin lymphomas.
Bone marrow biopsy morbidity and mortality. [2022]A postal survey of adverse events associated with bone marrow biopsy (aspiration biopsy with or without trephine biopsy) was carried out among British Society of Haematology members, between 1995 and 2001. A total of 26 adverse events, including one death directly attributable to the procedure, were reported among an estimated 54 890 biopsies. The most frequent and most serious adverse event was haemorrhage, reported in 14 patients, necessitating blood transfusion in six patients and leading to the single death. The potential risk factors most often associated with haemorrhage were a diagnosis of a myeloproliferative disorder, aspirin therapy or both. Other potential risk factors were warfarin therapy, disseminated intravascular coagulation and obesity.
[Bone marrow aspiration for diagnostic purposes]. [2006]Examination of bone marrow aspiration is an important tool in the diagnosis of haematological diseases. First attempts of bone marrow sampling took place at the beginning of the twentieth century. Thereafter, numerous methods were proposed and different materials were described. The commonly accepted sites for sampling are sternum and the iliac crest. We describe here a sampling procedure for each site. Bone marrow aspiration is a safely investigation, but not recommended for patients with impaired haemostasis. The physician must be aware of its side effects and complications which could occur. The consequence of the complications varies according to the type of iatrogenic injury. Prevention and rapid diagnosis are a crucial point in the management of bone marrow aspiration accidents. To avoid malpractice, the procedure should be taught by senior physicians including theoretical as well as practical learning. The purpose of the learning is a high quality of care to ensure patients the best comfort in subsequent bone marrow examinations, this point being particularly important in paediatrics.
Bone marrow sampling. [2004]Bone marrow sampling may be indicated in the evaluation of iron metabolism, fever of unknown origin, anemia, leukocytosis and other hematologic abnormalities. The commonly accepted means of marrow sampling are needle aspiration and needle biopsy. The preferred site for obtaining the sample is the iliac crest. Contraindications to the procedure include infection or previous radiation therapy at the sample site, poor patient cooperation and major coagulation defects. The assistance of a skilled technician, use of a prepackaged tray, thorough patient education, use of local anesthesia and attention to aseptic technique help simplify bone marrow sampling.
Penetrating injury of the ascending aorta complicating a sternal biopsy. [2018]Bone marrow aspiration and trephine biopsy are considered safe procedures. Some serious but rare adverse events directly attributable to these procedures have been related in a few reports in the literature. We report a rare case of ascending aortic injury following a sternal trephine biopsy.