Pleural EffusionSENSHIPNCT06314620
Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency
A study testing Heparin saline lock and Without heparin saline lock in people with Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Heparin saline lock and Without heparin saline lock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Mar 2024to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted in medical wards for pleural effusion who had small bore intercostal catheters inserted.
Who cannot join
- Patients with hydropneumothorax with small bore intercostal catheters
- Patients with septated effusion planned for intrapleural fibrinolysis
- Patients with severe coagulopathy
- INR ≥ 1.5
- PT > 37s
- aPTT > 100s
Show all 11Show fewer
- Patients with thrombocytopenia of less than 50 x 109/L
- Patients who has not consented to be involved in the study
- Patients with indwelling pleural catheters
- Unconscious patients will be excluded from this study
- Patients with poor GCS score will be excluded from this study
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 53300
About this study
Official title: Safety And Efficacy Of 8 Hourly Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency ; A Prospective Pilot Study
Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results.
Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently , in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures.
Read more
British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions.
The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement.
There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion.
Read the detailed description
Hypothesis
- Rate of occlusion is less in group with Heparin Saline lock.
- Rate of occlusions is higher in patients with exudative effusions. e.g : Empyema, raised pleural fluid LDH, low pleural pH, positive pleural cultures.
- Onset of ICC occlusions is lower in group with Heparin Saline lock.
- There is no difference in blood parameters between 2 groups.
- There are no apparent adverse effects between 2 groups.
- Patients in group with Heparin Saline lock have lower numbers of fenestration occluded.
Significance of Research Pleural diseases are among the most common diseases encountered in tertiary hospitals in Malaysia. Healthcare providers will need to provide adequate drainage of pleural fluids to improve the treatment outcome of patients. One of the mainstays of treatment is to ensure adequate drainage by reducing the rate of blockage of chest drains. This study is a pilot study to determine the efficacy as well as to ascertain the safety profile of using normal saline vs heparin saline lock for small bore intercostal catheters among pleural disease patients.
Type of Study Study on the Safety and Efficacy of 8 Hourly Flushing of ICC with and without Heparin Saline Lock in Maintaining Patency of ICC (SENSHIP Trial) is a prospective open label randomized controlled trial , a pilot study of patients admitted with pleural diseases in need of small bore intercostal catheters in Hospital Canselor Tuanku Muhriz, HUKM.
Standard Of Care Current Standard of Care in managing ICC in pleural diseases follows the recommendation of British Thoracic Society Guidelines where it suggests for regular flushing of ICC. The guideline recommends flushing of the tube by instilling 20-30ml of Normal Saline flush every 6 to 8 hours by a three way stopcock. However, this guideline only recommends regular flushing with Normal Saline and no research has been conducted to compare the outcome of effusions drainage and rates of blockage in small bore chest tubes with different techniques of flushing. Despite regular flushing with Normal Saline solutions as recommended, the rate of blockages in ICC still remains high. Hence, by adapting the concept of Heparin Saline Lock in IJC to maintain the patency of the tubing, we would like to study the difference of regular 8 hourly Normal Saline flushing with and without Heparin Saline Lock in maintaining ICC. Participants in this study who are chosen into Heparin Saline Lock arm will be receiving approximately 2ml of Heparin Saline as locking solution in attempt to maintain the ICC tube.
This study will be conducted in all medical wards of Hospital Canselor Tuanku Muhriz, HUKM.
Sampling Population
This study will be conducted among inpatients in medical wards with pleural effusions requiring small bore intercostal chest catheters who had been screened and consented to be involved in this study. All participants will be randomly allocated into 2 groups :
- Group without Heparin Saline Lock
- Group with Heparin Saline Lock
The group with heparin saline lock will receive approximately 1-2mls Heparin Saline as a locking solution (depending on the length of catheter). The amount of Heparin Saline lock to be instilled will depends on the estimated catheter volume. After flushing, the catheter will be clamped for 1 hour and then unclamped after 1 hour. Data will then be collected from 2 different groups to be analysed.
Sample Size Sample size is calculated using 'Select Statistical Online Calculator'; using 2 sample comparisons of percentages. There were no previous study comparing the efficacy and safety of Heparin Saline Lock vs Normal Saline Lock in maintaining the patency of small-bore ICC, thus the sample size calculated using the study conducted previous study by Claire. The study reported a 32% reduction in pleural fluid volume on CT over 3 days in the irrigation group compared to a 15% reduction in patients treated with chest-tube drainage alone (p<0.04).
Estimated sample size for two-sample comparison of percentages
Assumptions:
Alpha = 5% (two-sided) Power = 80% Intervention (Heparin) = 32% Standard (NS) = 15%
Estimated sample size:
n1 (Heparin) = 96 n2 (NS) = 96
Missing data estimated to be 10%, therefore minimum total sample required is 212 (Intervention = 106 , Standard = 106)
However, as this is a pilot study, the estimated sample size taken for this study is 20% from the calculated sample size with missing data estimated to be 10%.
Estimated sample size :
n1 (Heparin) : 20 n2 (NS) : 20
Therefore, minimum total sample needed is 40
Statistical Analysis
Statistical analyses will be performed with SPSS v23 software. Descriptive statistics, such as the frequency (n), arithmetic mean (x), and standard deviation (SD), are presented for normally distributed variables. A 2- sample independent test for mean and proportions will be used to calculate the statistical significance value between the 2 independent groups. Statistical significance was defined as p<0.05.
- Conditions
- Pleural Effusion
- Being tested
- Heparin saline lock, Without heparin saline lock
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin saline lockDrug
Participants with intercostal chest catheter who underwent normal saline flushing with heparin saline lock
Without heparin saline lockOther
Participants with intercostal chest catheter who underwent normal saline flushing without heparin saline lock
| Study group | Role | What they receive |
|---|---|---|
| Participants who underwent ICC with normal saline flushing and heparin lock | Active comparator | Participants who underwent intercostal chest catheter with normal saline flushing with heparin lock. Instillation done with 20 mls of Normal Saline flush followed by heparin saline lock, every 6 hours by a three way stopcock. Receives: Drug: Heparin saline lock |
| Participants who underwent ICC with normal saline flushing without heparin lock | Active comparator | Participants who underwent intercostal chest catheter with normal saline flushing without heparin lock. Instillation done with 20 mls of Normal Saline flush , every 6 hours by a three way stopcock. Receives: Other: Without heparin saline lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
Measured: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
Secondary outcomes (5)
To determine the onset of intercostal chest catheter occlusions (in hours)
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
Measured: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To determine the change of hemoglobin (in g/dL) post ICC insertion
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
Measured: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To determine the change of platelet (in 10 9/L) post ICC insertion
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
Measured: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To determine the adverse effects of heparin saline lock
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
Measured: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
Measured: From the time of randomization to the time of the end of study up to up to 30 days post insertion of chest drain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Mar 2024
- Primary completion10 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Faisal Abdul Hamid, MBBS (IIUM), Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314620
- Sponsor's protocol ID
- FF-2024-043
- Acronym
- SENSHIP
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horsley A, Jones L, White J, Henry M. Efficacy and complications of small-bore, wire-guided chest drains. Chest. 2006 Dec;130(6):1857-63. doi: 10.1378/chest.130.6.1857.
PubMed 17167009Maskell N; British Thoracic Society Pleural Disease Guideline Group. British Thoracic Society Pleural Disease Guidelines--2010 update. Thorax. 2010 Aug;65(8):667-9. doi: 10.1136/thx.2010.140236. No abstract available.
PubMed 20685739Keeling AN, Leong S, Logan PM, Lee MJ. Empyema and effusion: outcome of image-guided small-bore catheter drainage. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):135-41. doi: 10.1007/s00270-007-9197-0. Epub 2007 Oct 18.
PubMed 17943347Davies HE, Merchant S, McGown A. A study of the complications of small bore 'Seldinger' intercostal chest drains. Respirology. 2008 Jun;13(4):603-7. doi: 10.1111/j.1440-1843.2008.01296.x. Epub 2008 Apr 14.
PubMed 18422864Porcel JM, Azzopardi M, Koegelenberg CF, Maldonado F, Rahman NM, Lee YC. The diagnosis of pleural effusions. Expert Rev Respir Med. 2015;9(6):801-15. doi: 10.1586/17476348.2015.1098535. Epub 2015 Oct 8.
PubMed 26449328Parulekar W, Di Primio G, Matzinger F, Dennie C, Bociek G. Use of small-bore vs large-bore chest tubes for treatment of malignant pleural effusions. Chest. 2001 Jul;120(1):19-25. doi: 10.1378/chest.120.1.19.
PubMed 11451810Mehra S, Heraganahally S, Sajkov D, Morton S, Bowden J. The effectiveness of small-bore intercostal catheters versus large-bore chest tubes in the management of pleural disease with the systematic review of literature. Lung India. 2020 May-Jun;37(3):198-203. doi: 10.4103/lungindia.lungindia_229_19.
PubMed 32367840Collop NA, Kim S, Sahn SA. Analysis of tube thoracostomy performed by pulmonologists at a teaching hospital. Chest. 1997 Sep;112(3):709-13. doi: 10.1378/chest.112.3.709.
PubMed 9315804Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.
PubMed 26022948Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.
PubMed 26075094Shaikh N. Heparin-induced thrombocytopenia. J Emerg Trauma Shock. 2011 Jan;4(1):97-102. doi: 10.4103/0974-2700.76843.
PubMed 21633576
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Of 8 Hourly Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency ; A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT06314620
- Acronym / sponsor ID
- SENSHIP / FF-2024-043
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 18 Mar 2024 (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.
Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results.
Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently , in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures.
British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions.
The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement.
There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion.
Detailed description
Hypothesis
- Rate of occlusion is less in group with Heparin Saline lock.
- Rate of occlusions is higher in patients with exudative effusions. e.g : Empyema, raised pleural fluid LDH, low pleural pH, positive pleural cultures.
- Onset of ICC occlusions is lower in group with Heparin Saline lock.
- There is no difference in blood parameters between 2 groups.
- There are no apparent adverse effects between 2 groups.
- Patients in group with Heparin Saline lock have lower numbers of fenestration occluded.
Significance of Research Pleural diseases are among the most common diseases encountered in tertiary hospitals in Malaysia. Healthcare providers will need to provide adequate drainage of pleural fluids to improve the treatment outcome of patients. One of the mainstays of treatment is to ensure adequate drainage by reducing the rate of blockage of chest drains. This study is a pilot study to determine the efficacy as well as to ascertain the safety profile of using normal saline vs heparin saline lock for small bore intercostal catheters among pleural disease patients.
Type of Study Study on the Safety and Efficacy of 8 Hourly Flushing of ICC with and without Heparin Saline Lock in Maintaining Patency of ICC (SENSHIP Trial) is a prospective open label randomized controlled trial , a pilot study of patients admitted with pleural diseases in need of small bore intercostal catheters in Hospital Canselor Tuanku Muhriz, HUKM.
Standard Of Care Current Standard of Care in managing ICC in pleural diseases follows the recommendation of British Thoracic Society Guidelines where it suggests for regular flushing of ICC. The guideline recommends flushing of the tube by instilling 20-30ml of Normal Saline flush every 6 to 8 hours by a three way stopcock. However, this guideline only recommends regular flushing with Normal Saline and no research has been conducted to compare the outcome of effusions drainage and rates of blockage in small bore chest tubes with different techniques of flushing. Despite regular flushing with Normal Saline solutions as recommended, the rate of blockages in ICC still remains high. Hence, by adapting the concept of Heparin Saline Lock in IJC to maintain the patency of the tubing, we would like to study the difference of regular 8 hourly Normal Saline flushing with and without Heparin Saline Lock in maintaining ICC. Participants in this study who are chosen into Heparin Saline Lock arm will be receiving approximately 2ml of Heparin Saline as locking solution in attempt to maintain the ICC tube.
This study will be conducted in all medical wards of Hospital Canselor Tuanku Muhriz, HUKM.
Sampling Population
This study will be conducted among inpatients in medical wards with pleural effusions requiring small bore intercostal chest catheters who had been screened and consented to be involved in this study. All participants will be randomly allocated into 2 groups :
- Group without Heparin Saline Lock
- Group with Heparin Saline Lock
The group with heparin saline lock will receive approximately 1-2mls Heparin Saline as a locking solution (depending on the length of catheter). The amount of Heparin Saline lock to be instilled will depends on the estimated catheter volume. After flushing, the catheter will be clamped for 1 hour and then unclamped after 1 hour. Data will then be collected from 2 different groups to be analysed.
Sample Size Sample size is calculated using 'Select Statistical Online Calculator'; using 2 sample comparisons of percentages. There were no previous study comparing the efficacy and safety of Heparin Saline Lock vs Normal Saline Lock in maintaining the patency of small-bore ICC, thus the sample size calculated using the study conducted previous study by Claire. The study reported a 32% reduction in pleural fluid volume on CT over 3 days in the irrigation group compared to a 15% reduction in patients treated with chest-tube drainage alone (p<0.04).
Estimated sample size for two-sample comparison of percentages
Assumptions:
Alpha = 5% (two-sided) Power = 80% Intervention (Heparin) = 32% Standard (NS) = 15%
Estimated sample size:
n1 (Heparin) = 96 n2 (NS) = 96
Missing data estimated to be 10%, therefore minimum total sample required is 212 (Intervention = 106 , Standard = 106)
However, as this is a pilot study, the estimated sample size taken for this study is 20% from the calculated sample size with missing data estimated to be 10%.
Estimated sample size :
n1 (Heparin) : 20 n2 (NS) : 20
Therefore, minimum total sample needed is 40
Statistical Analysis
Statistical analyses will be performed with SPSS v23 software. Descriptive statistics, such as the frequency (n), arithmetic mean (x), and standard deviation (SD), are presented for normally distributed variables. A 2- sample independent test for mean and proportions will be used to calculate the statistical significance value between the 2 independent groups. Statistical significance was defined as p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who underwent ICC with normal saline flushing and heparin lock | Active comparator | Drug: Heparin saline lockParticipants who underwent intercostal chest catheter with normal saline flushing with heparin lock. Instillation done with 20 mls of Normal Saline flush followed by heparin saline lock, every 6 hours by a three way stopcock. |
| Participants who underwent ICC with normal saline flushing without heparin lock | Active comparator | Other: Without heparin saline lockParticipants who underwent intercostal chest catheter with normal saline flushing without heparin lock. Instillation done with 20 mls of Normal Saline flush , every 6 hours by a three way stopcock. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted in medical wards for pleural effusion who had small bore intercostal catheters inserted.
Key exclusion criteria (11 listed)
- Patients with hydropneumothorax with small bore intercostal catheters
- Patients with septated effusion planned for intrapleural fibrinolysis
- Patients with severe coagulopathy
- Patients with thrombocytopenia of less than 50 x 109/L
- Patients who has not consented to be involved in the study
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 |
|---|---|---|
| Heparin saline lockParticipants with intercostal chest catheter who underwent normal saline flushing with heparin saline lock | Drug | Participants who underwent ICC with normal saline flushing and heparin lock |
| Without heparin saline lockParticipants with intercostal chest catheter who underwent normal saline flushing without heparin saline lock | Other | Participants who underwent ICC with normal saline flushing without heparin lock |
Primary outcome
To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock
Time frame: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
Participants who underwent intercostal chest catheter insertion who received normal saline flushing with and without heparin lock.
5 secondary outcomes
To determine the onset of intercostal chest catheter occlusions (in hours)
Time frame: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To determine the change of hemoglobin (in g/dL) post ICC insertion
Time frame: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To determine the change of platelet (in 10 9/L) post ICC insertion
Time frame: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To determine the adverse effects of heparin saline lock
Time frame: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain
To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots
Time frame: From the time of randomization to the time of the end of study up to up to 30 days post insertion of chest drain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 17167009Horsley A, Jones L, White J, Henry M. Efficacy and complications of small-bore, wire-guided chest drains. Chest. 2006 Dec;130(6):1857-63. doi: 10.1378/chest.130.6.1857.
- Results publication: PubMed 20685739Maskell N; British Thoracic Society Pleural Disease Guideline Group. British Thoracic Society Pleural Disease Guidelines--2010 update. Thorax. 2010 Aug;65(8):667-9. doi: 10.1136/thx.2010.140236. No abstract available.
- Results publication: PubMed 17943347Keeling AN, Leong S, Logan PM, Lee MJ. Empyema and effusion: outcome of image-guided small-bore catheter drainage. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):135-41. doi: 10.1007/s00270-007-9197-0. Epub 2007 Oct 18.
- Results publication: PubMed 18422864Davies HE, Merchant S, McGown A. A study of the complications of small bore 'Seldinger' intercostal chest drains. Respirology. 2008 Jun;13(4):603-7. doi: 10.1111/j.1440-1843.2008.01296.x. Epub 2008 Apr 14.
- Results publication: PubMed 26449328Porcel JM, Azzopardi M, Koegelenberg CF, Maldonado F, Rahman NM, Lee YC. The diagnosis of pleural effusions. Expert Rev Respir Med. 2015;9(6):801-15. doi: 10.1586/17476348.2015.1098535. Epub 2015 Oct 8.
- Results publication: PubMed 11451810Parulekar W, Di Primio G, Matzinger F, Dennie C, Bociek G. Use of small-bore vs large-bore chest tubes for treatment of malignant pleural effusions. Chest. 2001 Jul;120(1):19-25. doi: 10.1378/chest.120.1.19.
- Results publication: PubMed 32367840Mehra S, Heraganahally S, Sajkov D, Morton S, Bowden J. The effectiveness of small-bore intercostal catheters versus large-bore chest tubes in the management of pleural disease with the systematic review of literature. Lung India. 2020 May-Jun;37(3):198-203. doi: 10.4103/lungindia.lungindia_229_19.
- Results publication: PubMed 9315804Collop NA, Kim S, Sahn SA. Analysis of tube thoracostomy performed by pulmonologists at a teaching hospital. Chest. 1997 Sep;112(3):709-13. doi: 10.1378/chest.112.3.709.
- Results publication: PubMed 26022948Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.
- Results publication: PubMed 26075094Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.
- Results publication: PubMed 21633576Shaikh N. Heparin-induced thrombocytopenia. J Emerg Trauma Shock. 2011 Jan;4(1):97-102. doi: 10.4103/0974-2700.76843.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohamed Faisal Abdul Hamid, MBBS (IIUM) principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin saline lock and Without heparin saline lock in people with Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
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 1 inclusion and 11 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: finished, as of the sponsor's last update on 15 Sep 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock (time frame: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain). 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 NCT06314620, which also lists 11 linked publications.
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 15 Sep 2026.