Trial Outcomes & Findings for The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery (NCT NCT05251805)

Last Updated: 2025-06-08

Results Overview

All adverse events will be classified by the Clavien Dindo classification. The study will be closed prematurely if 2 patients experience a grade 3 adverse event directly related to the bone marrow aspiration

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

7 days following surgery

Results posted on

2025-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Costal Bone Marrow Aspiration 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected Blood, bone marrow and lung tumor tissue collection: Blood sampling: 12ml of blood will be collected during the routine pre-operative blood collection Bone marrow aspiration during thoracic surgery: following the surgical intervention, bone marrow aspiration will be performed through the incisions made for the thoracic procedure. The ribs lying directly above and below the trocar incision will be exposed. A bone marrow needle will be advanced into the periost until the needle tip reaches the bone marrow. After removing the stylet a 2ml syringe will be attached to the aspiration needle and 0.5ml to 2ml of bone marrow will be aspirated before removing the needle. This procedure will be repeated twice for every trocar site, for a maximum of 3 trocar sites, or until 5ml of bone marrow aspirate is obtained. Lung tumor collection: all surgical samples will be analyzed by our anatomopathological department. Viable and fresh material, not used for the diagnostic purposes, will be sent to the LMCT.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Costal Bone Marrow Aspiration n=4 Participants 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected Blood, bone marrow and lung tumor tissue collection: Blood sampling: 12ml of blood will be collected during the routine pre-operative blood collection Bone marrow aspiration during thoracic surgery: following the surgical intervention, bone marrow aspiration will be performed through the incisions made for the thoracic procedure. The ribs lying directly above and below the trocar incision will be exposed. A bone marrow needle will be advanced into the periost until the needle tip reaches the bone marrow. After removing the stylet a 2ml syringe will be attached to the aspiration needle and 0.5ml to 2ml of bone marrow will be aspirated before removing the needle. This procedure will be repeated twice for every trocar site, for a maximum of 3 trocar sites, or until 5ml of bone marrow aspirate is obtained. Lung tumor collection: all surgical samples will be analyzed by our anatomopathological department. Viable and fresh material, not used for the diagnostic purposes, will be sent to the LMCT.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=4 Participants
Region of Enrollment Belgium	4 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 days following surgery

Outcome measures

Outcome measures
Measure	Costal Bone Marrow Aspiration n=4 Participants 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected Blood, bone marrow and lung tumor tissue collection: Blood sampling: 12ml of blood will be collected during the routine pre-operative blood collection Bone marrow aspiration during thoracic surgery: following the surgical intervention, bone marrow aspiration will be performed through the incisions made for the thoracic procedure. The ribs lying directly above and below the trocar incision will be exposed. A bone marrow needle will be advanced into the periost until the needle tip reaches the bone marrow. After removing the stylet a 2ml syringe will be attached to the aspiration needle and 0.5ml to 2ml of bone marrow will be aspirated before removing the needle. This procedure will be repeated twice for every trocar site, for a maximum of 3 trocar sites, or until 5ml of bone marrow aspirate is obtained. Lung tumor collection: all surgical samples will be analyzed by our anatomopathological department. Viable and fresh material, not used for the diagnostic purposes, will be sent to the LMCT.
The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo	6 total of adverse events Interval 2.0 to 11.0

SECONDARY outcome

Timeframe: 7 days following aspiration from the bone marrow

Population: the HPSC's couldn't be measured as the bone marrow aspiration stayed unsuccesfull. hPSC's needed to be extracted from the costal bone marrow. However, since the bone marrow aspiration from the costal bone marrow stayed unsuccesfull, no hPSC's could be extracted and thus the amount could not be measured.

a minimum of 2x106 Lin- CD34+ HPSC are required to allow single cell sequencing, 3D bone marrow cultivation and transplantation in immunodeficient mice.

Outcome measures

Outcome data not reported

Adverse Events

Costal Bone Marrow Aspiration

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Costal Bone Marrow Aspiration n=4 participants at risk 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected Blood, bone marrow and lung tumor tissue collection: Blood sampling: 12ml of blood will be collected during the routine pre-operative blood collection Bone marrow aspiration during thoracic surgery: following the surgical intervention, bone marrow aspiration will be performed through the incisions made for the thoracic procedure. The ribs lying directly above and below the trocar incision will be exposed. A bone marrow needle will be advanced into the periost until the needle tip reaches the bone marrow. After removing the stylet a 2ml syringe will be attached to the aspiration needle and 0.5ml to 2ml of bone marrow will be aspirated before removing the needle. This procedure will be repeated twice for every trocar site, for a maximum of 3 trocar sites, or until 5ml of bone marrow aspirate is obtained. Lung tumor collection: all surgical samples will be analyzed by our anatomopathological department. Viable and fresh material, not used for the diagnostic purposes, will be sent to the LMCT.
Gastrointestinal disorders Nausea	75.0% 3/4 • Number of events 4 • all adverse events were captured from signing the ICF till 30 days post surgery
Infections and infestations injection site reaction	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
Blood and lymphatic system disorders Hypoxia	50.0% 2/4 • Number of events 5 • all adverse events were captured from signing the ICF till 30 days post surgery
Blood and lymphatic system disorders hypokalemia	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
General disorders fever	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
Blood and lymphatic system disorders hypotension	50.0% 2/4 • Number of events 2 • all adverse events were captured from signing the ICF till 30 days post surgery
Gastrointestinal disorders constipation	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
Respiratory, thoracic and mediastinal disorders pneumothorax	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
Blood and lymphatic system disorders phlebitis	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
General disorders itchy back	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
General disorders sleeplessness	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
Gastrointestinal disorders stomach ache	25.0% 1/4 • Number of events 1 • all adverse events were captured from signing the ICF till 30 days post surgery
General disorders stress	50.0% 2/4 • Number of events 2 • all adverse events were captured from signing the ICF till 30 days post surgery

Additional Information

Head of the anesthesiology department

UZ Brussel

Phone: 024776001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place