Prospective Bone Marrow Biopsy Safety and Efficacy Study

Bone Marrow Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02524613
• Other study ID #: 2015-4653
• Status: Active, not recruiting
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 13, 2015
• Start date: July 2015

Study information

• Verified date: August 2015
• Source: Jacobi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Marrow

Intervention

Other:
• Pelvis CT scan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jacobi Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rates associated with bone marrow biopsy	Complications will be assessed by a modified pelvic CT	5 days after the bone marrow biopsy	No
Primary	Quality of bone marrow biopsy	Length of the bone marrow biospy specimen in mm is measured by a pathologist blindly	5 days after the bone marrow biopsy	No