Drug Abuse, IntravenousNCT05679284
A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs
An observational study of Drug Abuse, Intravenous and Substance Dependence, run by Tampere University Hospital at 1 site in Finland.
Trial summary
In addition to the well-known toxicological harms of intravenous drug (IVD) use, there can also be local tissue complications, including infections, venous sclerosis, tissue necrosis, and drug needle fragment retentions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Abuse, Intravenous, Substance Dependence, Needle Injury
- What is being tested?
- Low-dose X-ray of subcutaneous tissues
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 25 May 2023to 15 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The population base is the adult IVD users from the drug abuse treatment centres in Tampere, Finland.
Who may be able to join
- History of intravenous drug use
- Current treatment of the drug abuse problem at a local low-threshold drug abuse service unit or primary health care centre.
- Adherence to fill in the questionnaire
- Participation to X-ray imaging of injection sites
Who cannot join
- No history of intravenous drug use
- Does not adhere to fill in the questionnaire or refuses X-ray imaging
- Pregnancy
- Underage (18 years old)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Hatanpää Health Center
Tampere
040 8063649
About this study
Official title: The Prevalence and Predisposing Factors to Retained Drug Needle Fragments in People Who Inject Drugs: a Protocol for a Cross-sectional Observational Study
In addition to the well-known toxicological harms of intravenous drug (IVD) use, there can also be local tissue complications, including infections, venous sclerosis, tissue necrosis, and drug needle fragment retentions. Drug needle fragments in subcutaneous tissue may cause local symptoms (usually pain and infections), but they have also been identified as causing emboli to organs. The literature has described numerous case reports of people who inject drugs (PWIDs) and have retained needle fragments. The prevalence of the condition is not known, and the researchers therefore aim to perform the first cross-sectional study of PWIDs to estimate how common needle fragment retentions are and what their risk factors are in this population.
Read the detailed description
The clinical significance of retained needle fragments remains unknown. Needle retentions can be asymptomatic, cause local symptoms, and can sometimes even lead to dangerous complications such as needle emboli to the heart or lungs. The most common injection sites are likely the peripheral veins of the arms. However, continuous IVD use leads to vein sclerosis, and patients with long-term use may therefore also use peripheral veins of their lower limbs and even the central veins of the groin or neck. Subcutaneously retained needles can pose a risk of needlestick injury to medical staff during clinical examination and treatment procedures. Unrecognized retained needles can also cause hazards during magnetic resonance imaging.
The study protocol received a positive review from the Tampere University Hospital Ethics Committee (study code: R22037). The researchers subsequently received the organizational permissions necessary to conduct the study. PWIDs will be asked to give written informed consent prior to any study procedures. Participants will be asked to fill in a questionnaire about their basic information, drug use history, previous injection sites, and whether they have had any local complications due to injecting drugs. After the completion of the questionnaire, participants will undergo targeted X-ray imaging of the injection sites. As metallic objects, needle fragments can be visualized with standard X-ray imaging. Female participants of childbearing potential (< 50 years) will undergo urine sample pregnancy testing prior to X-ray imaging. A pilot study with 20 participants will be conducted first. Experiences from the pilot will be used to refine the study protocol if needed. If modifications are made, they will be subjected to ethics review and will be provided on ClinicalTrials.gov. After the pilot study, the researchers aim to recruit an additional 80 patients (totaling up to 100 participants).
Our research questions are 1) What is the prevalence of radiologically confirmed needle retention among PWIDs*? The secondary research questions are
- Do patient-reported symptoms and the suspicion of a retained needle fragments correspond to radiologically confirmed needle retention?
- What are the predisposing factors to needle fragmentation?
- Have PWIDs sought medical attention prior to the study for possible symptoms in the injection sites?
- How frequently are verified needle fragments surgically removed within five years after their detection, and are verified needle fragments a proxy or a risk factor for mortality? *As only patients in outpatient care will be recruited, the sample is not entirely representative of all PWIDs in the study area (e.g., people who are hospitalized or imprisoned are not recruited).
- Conditions
- Drug Abuse, Intravenous, Substance Dependence, Needle Injury, Soft Tissue Injuries, Foreign Bodies
- Being tested
- Low-dose X-ray of subcutaneous tissues
- Keywords
- Intravenous drug use, needle retention, needle fragment
- Medical subject headings
- Substance Abuse, Intravenous, Substance-Related Disorders, Soft Tissue Injuries, Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose X-ray of subcutaneous tissuesRadiation
To identify needle fragment retentions, the radiologic imaging of all volunteers will be performed with X-ray using radiation doses as low as reasonably achievable (ALARA) and one projection per anatomic site.
| Study group | Role | What they receive |
|---|---|---|
| Cases: Intravenous drug users with drug needle fragment retentions | All intravenous drug users from the service units will be asked to participate. X-ray imaging has the goal to identify patients with needle fragment retentions in subcutaneous tissue. Receives: Radiation: Low-dose X-ray of subcutaneous tissues | |
| Controls: Intravenous drug users without drug needle fragment retentions | All intravenous drug users from the service units will be asked to participate. Control group consists of those with no radiologically confirmed subcutaneous needle fragment retentions. Receives: Radiation: Low-dose X-ray of subcutaneous tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of needle fragment retentions among intravenous drug users.
The prevalence of needle fragment retentions among intravenous drug users. The number of individuals with at least one radiologically confirmed needle fragment in subcutaneous tissue over the total number of participants.
Measured: An average of 2 years.
Risk factors for needle fragment retentions in a cross-sectional design
Risk factors for needle fragment retentions in a cross-sectional design. Patient characteristics as risk factors for having subcutaneous needle fragment retentions.
Measured: An average of 2 years.
The proportion of patients with surgically removed needle fragment retentions at five years of follow-up.
The proportion of patients with surgically removed needle fragment retentions after five years of follow-up. Patients with needle fragment retentions will be referred to the surgical clinic and will be prospectively followed up through healthcare records.
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start25 May 2023
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Abuse, IntravenousStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Deaconess Foundation, A-Clinic Foundation
- Responsible party
- Sponsor
- Investigators
- Otso Arponen, MD-PhD, Study chair, Pirkanmaa Hospital District (PSHP)Olli PO Nevalainen, MD-PhD, Study chair, City of Tampere; Tampere University; Pirkanmaa Hospital District (PSHP).Irina Rinta-Kiikka, MD-PhD, Study chair, Tampere University HospitalHeidi Laukkala, MD, Study chair, City of Tampere, Tampere UniversityMarkku Sumanen, MD-PhD, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679284
- Sponsor's protocol ID
- Retained drug needles
- Status last verified
- May 2023
- First submitted
- 22 Oct 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share individual-level data with other investigators.
Publications
Laukkala H, Arponen O, Rinta-Kiikka I, Sumanen M, Nevalainen OPO. Prevalence and predisposing factors of retained drug needle fragments in people who inject drugs: a protocol for a preliminary cross-sectional multicentre observational study in Finland. BMJ Open. 2025 Aug 10;15(8):e099521. doi: 10.1136/bmjopen-2025-099521.
PubMed 40784774
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Predisposing Factors to Retained Drug Needle Fragments in People Who Inject Drugs: a Protocol for a Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT05679284
- Acronym / sponsor ID
- Retained drug needles
- Conditions
- Drug Abuse, Intravenous, Substance Dependence, Needle Injury, Soft Tissue Injuries, Foreign Bodies
- Keywords
- Intravenous drug use, needle retention, needle fragment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Deaconess Foundation, A-Clinic Foundation
- Study start
- 25 May 2023 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In addition to the well-known toxicological harms of intravenous drug (IVD) use, there can also be local tissue complications, including infections, venous sclerosis, tissue necrosis, and drug needle fragment retentions. Drug needle fragments in subcutaneous tissue may cause local symptoms (usually pain and infections), but they have also been identified as causing emboli to organs. The literature has described numerous case reports of people who inject drugs (PWIDs) and have retained needle fragments. The prevalence of the condition is not known, and the researchers therefore aim to perform the first cross-sectional study of PWIDs to estimate how common needle fragment retentions are and what their risk factors are in this population.
Detailed description
The clinical significance of retained needle fragments remains unknown. Needle retentions can be asymptomatic, cause local symptoms, and can sometimes even lead to dangerous complications such as needle emboli to the heart or lungs. The most common injection sites are likely the peripheral veins of the arms. However, continuous IVD use leads to vein sclerosis, and patients with long-term use may therefore also use peripheral veins of their lower limbs and even the central veins of the groin or neck. Subcutaneously retained needles can pose a risk of needlestick injury to medical staff during clinical examination and treatment procedures. Unrecognized retained needles can also cause hazards during magnetic resonance imaging.
The study protocol received a positive review from the Tampere University Hospital Ethics Committee (study code: R22037). The researchers subsequently received the organizational permissions necessary to conduct the study. PWIDs will be asked to give written informed consent prior to any study procedures. Participants will be asked to fill in a questionnaire about their basic information, drug use history, previous injection sites, and whether they have had any local complications due to injecting drugs. After the completion of the questionnaire, participants will undergo targeted X-ray imaging of the injection sites. As metallic objects, needle fragments can be visualized with standard X-ray imaging. Female participants of childbearing potential (< 50 years) will undergo urine sample pregnancy testing prior to X-ray imaging. A pilot study with 20 participants will be conducted first. Experiences from the pilot will be used to refine the study protocol if needed. If modifications are made, they will be subjected to ethics review and will be provided on ClinicalTrials.gov. After the pilot study, the researchers aim to recruit an additional 80 patients (totaling up to 100 participants).
Our research questions are 1) What is the prevalence of radiologically confirmed needle retention among PWIDs*? The secondary research questions are
- Do patient-reported symptoms and the suspicion of a retained needle fragments correspond to radiologically confirmed needle retention?
- What are the predisposing factors to needle fragmentation?
- Have PWIDs sought medical attention prior to the study for possible symptoms in the injection sites?
- How frequently are verified needle fragments surgically removed within five years after their detection, and are verified needle fragments a proxy or a risk factor for mortality? *As only patients in outpatient care will be recruited, the sample is not entirely representative of all PWIDs in the study area (e.g., people who are hospitalized or imprisoned are not recruited).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: Intravenous drug users with drug needle fragment retentions | – | Radiation: Low-dose X-ray of subcutaneous tissuesAll intravenous drug users from the service units will be asked to participate. X-ray imaging has the goal to identify patients with needle fragment retentions in subcutaneous tissue. |
| Controls: Intravenous drug users without drug needle fragment retentions | – | Radiation: Low-dose X-ray of subcutaneous tissuesAll intravenous drug users from the service units will be asked to participate. Control group consists of those with no radiologically confirmed subcutaneous needle fragment retentions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population base is the adult IVD users from the drug abuse treatment centres in Tampere, Finland.
Key inclusion criteria (4 listed)
- History of intravenous drug use
- Current treatment of the drug abuse problem at a local low-threshold drug abuse service unit or primary health care centre.
- Adherence to fill in the questionnaire
- Participation to X-ray imaging of injection sites
Key exclusion criteria (4 listed)
- No history of intravenous drug use
- Does not adhere to fill in the questionnaire or refuses X-ray imaging
- Pregnancy
- Underage (18 years old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose X-ray of subcutaneous tissuesTo identify needle fragment retentions, the radiologic imaging of all volunteers will be performed with X-ray using radiation doses as low as reasonably achievable (ALARA) and one projection per anatomic site. | Radiation | Cases: Intravenous drug users with drug needle fragment retentions, Controls: Intravenous drug users without drug needle fragment retentions |
Primary outcome
Prevalence of needle fragment retentions among intravenous drug users.
Time frame: An average of 2 years.
The prevalence of needle fragment retentions among intravenous drug users. The number of individuals with at least one radiologically confirmed needle fragment in subcutaneous tissue over the total number of participants.
Risk factors for needle fragment retentions in a cross-sectional design
Time frame: An average of 2 years.
Risk factors for needle fragment retentions in a cross-sectional design. Patient characteristics as risk factors for having subcutaneous needle fragment retentions.
The proportion of patients with surgically removed needle fragment retentions at five years of follow-up.
Time frame: Up to 5 years.
The proportion of patients with surgically removed needle fragment retentions after five years of follow-up. Patients with needle fragment retentions will be referred to the surgical clinic and will be prospectively followed up through healthcare records.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 40784774Laukkala H, Arponen O, Rinta-Kiikka I, Sumanen M, Nevalainen OPO. Prevalence and predisposing factors of retained drug needle fragments in people who inject drugs: a protocol for a preliminary cross-sectional multicentre observational study in Finland. BMJ Open. 2025 Aug 10;15(8):e099521. doi: 10.1136/bmjopen-2025-099521.
- Individual participant dataSharing planned: No. No plans to share individual-level data with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Otso Arponen, MD-PhD study chair
Pirkanmaa Hospital District (PSHP)
Olli PO Nevalainen, MD-PhD study chair
City of Tampere; Tampere University; Pirkanmaa Hospital District (PSHP).
Irina Rinta-Kiikka, MD-PhD study chair
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Abuse, Intravenous and Substance Dependence, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otso Arponen, Associate Professor, MD (+358 50 410 6170, otso.arponen@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of needle fragment retentions among intravenous drug users. (time frame: An average of 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05679284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.