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.
Is bone marrow aspiration a promising treatment for kidney transplant rejection?Bone marrow aspiration is mainly used for diagnosing blood-related diseases and conditions. It helps doctors understand what's happening in the bone marrow, which is where blood cells are made. While it's a valuable tool for diagnosis, the information provided doesn't specifically mention its use as a treatment for kidney transplant rejection.12456
What data supports the idea that Bone Marrow Aspiration for Kidney Transplant Rejection is an effective treatment?The available research does not provide specific data supporting the effectiveness of Bone Marrow Aspiration for Kidney Transplant Rejection. The studies focus on its use in other conditions, like detecting cancer in the bone marrow and evaluating blood cell production. Without direct evidence for kidney transplant rejection, we can't conclude its effectiveness for this specific treatment.25689
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic anticoagulation therapy with heparin or coumadin, or if you've taken investigational drugs within 14 days before enrollment.
What safety data exists for bone marrow aspiration in kidney transplant rejection?Bone marrow aspiration is generally considered a safe procedure, but it carries some risks. A study comparing a powered device to traditional methods found it to be associated with pain, procedure time, and safety concerns. Common complications include hemorrhage, especially in patients with coagulation issues or on certain medications like aspirin or warfarin. A survey reported 26 adverse events, including one death, out of 54,890 procedures. Rare but serious complications, such as aortic injury, have been documented. Proper training and technique are crucial to minimize risks.13467
Eligibility 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
I have antibodies against a kidney transplant as shown by a specific test.
Exclusion Criteria
I am currently on blood thinners like heparin or coumadin.
I cannot have a kidney transplant due to an infection or other health issues.
Treatment Details
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
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.
[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.
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.
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.
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.
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.
Safety of bone marrow aspiration and biopsy in severely thrombocytopenic patients. [2021]To assess the safety of fluoroscopically guided drill-assisted bone marrow aspirate and biopsy in severely thrombocytopenic patients.
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.