Clinical trial NCT02524613: Prospective Bone Marrow Biopsy Safety and Efficacy Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Marrow
Lead sponsor: Jacobi Medical Center
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult hematology patients who have just completed an elective bone marrow biopsy will be considered eligible for enrollment.

Brief summary: Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. However, a significant number are performed by hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of complications associated with bone marrow biopsy are largely unknown. This study has two goals:

1. The first goal is to objectively determine by CT and clinical assessment, the actual risk to patients of the bone marrow biopsy and the rate of pelvic injury in an unselected group of hematology patients requiring a bone marrow biopsy, as performed by hematologist-in-training.
2. The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have a hematological or oncological condition which requires a bone marrow aspiration and biopsy procedure, and no alternative procedures are available for diagnosis, staging, monitoring or follow up of their disease.
2. Subjects must be able to understand the risks/benefits and provide written informed consent to participate in the study, and be willing to participate in all required study activities for the duration of the study.
3. Subjects must be 40 years of age or older.

Exclusion Criteria:

1. Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
2. Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance.
3. Patients with uncontrolled bleeding disorders.
4. Pregnant and lactating females (due to radiation exposure during the CT scans).

Primary outcomes:
measure: Complication rates associated with bone marrow biopsy
timeFrame: 5 days after the bone marrow biopsy
measure: Quality of bone marrow biopsy
timeFrame: 5 days after the bone marrow biopsy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Reed LJ, Attarian S, Olson TR, Singh S, Shestopalov A, Friedman EW. Feasibility and safety of targeting the anterior superior iliac spine to perform a bone marrow procedure: a prospective, clinical study. J Clin Pathol. 2018 Dec;71(12):1116-1119. doi: 10.1136/jclinpath-2018-205309. Epub 2018 Oct 23.
citation: Attarian S, Reed L, Singh S, Shestopalov A, Singh AP, Budhathoki A, Abi-Aad S, Shah UA, Kim S, Bachiashvili K, Elrafei T, Li W, Yee C, Friedman EW. Visualization of the bone marrow biopsy needle track. Am J Hematol. 2018 Mar;93(3):E60-E61. doi: 10.1002/ajh.24985. Epub 2017 Dec 6. No abstract available.
citation: Reed L, Attarian S, Pendurti G, Singh AP, Budhathoki A, Abi-Aad S, Shah UA, Kim S, Bachiashvili K, Moon JY, Kim M, Elrafei T, Alexis K, Strakhan M, Li W, Friedman E. Targeting the anterior superior iliac spine yields significantly longer bone marrow cores. J Clin Pathol. 2018 Feb;71(2):172-173. doi: 10.1136/jclinpath-2017-204686. Epub 2017 Aug 26.