HypersplenismNCT05446116
Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism
A study testing partial splenic artery embolization in people with Hypersplenism, run by Zagazig University at 1 site in Egypt.
Trial summary
The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypersplenism
- What is being tested?
- partial splenic artery embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 18 Oct 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypersplenism and severe thrombocytopenia (platelet count < 50,000/mm3).
- the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR < 1.7, no ascites, no encephalopathy).
- Eligible for both femoral and radial puncture.
Who cannot join
- Patients referred for embolization as treatment of traumatic splenic injury.
- Patients lost during follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial
The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.
Read the detailed description
Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications.
PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.
- Conditions
- Hypersplenism
- Being tested
- partial splenic artery embolization
- Medical subject headings
- Hypersplenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial splenic artery embolizationProcedure or surgery
embolization of the splenic artery for the treatment of hypersplenism
| Study group | Role | What they receive |
|---|---|---|
| femoral puncture | Active comparator | Under local anaesthesia, the femoral artery was punctured and 6F sheath was inserted. Splenic artery was catheterized using 4- or 5-F catheters (Cobra C2 cat or Simmons II catheter Imager-Boston Scientific Natick, Massachusetts). Embolization was done using Embospheres (Biosphere Medical, Rockland, MA) 700-900 μ in diameter. Receives: Procedure: partial splenic artery embolization |
| Radial puncture | Active comparator | The left radial artery was preferred due to shorter distance from the left wrist to the splenic artery in comparison to the right wrist; also the left radial access theoretically decreases the risk of cerebral emboli. Under local anaesthesia and ultrasound guidance, the radial artery was punctured and 5- or 6-F sheath was introduced. After sheath insertion, the radial cocktail (2.5 mg of verapamil, 100 μg of nitroglycerin, and 5,000 units of heparin) was injected through the sheath over one minute after dilution with 20 ml of blood to decrease the discomfort during injection. Receives: Procedure: partial splenic artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of the Procedure
The achievement of a single puncture allowing access to splenic artery without periprocedural complications.
Measured: Immediately after the procedure is complete
Average number of punctures
Number of arterial punctures required to complete the procedure
Measured: Immediately after the procedure is complete
Procedural time
The time interval from starting the anaethesia till completion of the procedure
Measured: Immediately after the procedure is complete
X-ray exposure duration
Duration of flouroscopy exposure during the procedure
Measured: Immediately after the procedure is complete
Length of hospital stay
Number of days that the patient will spend in the hospital after the procedure.
Measured: 7 days
Complications at access site
Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding.
Measured: 30 days
Secondary outcomes (1)
Procedural complications
Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jun 2019
- Primary completion1 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersplenismStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed M.A. Zaitoun, Zagazig University
- Investigators
- Mohamed MA Zaitoun, MD, Principal investigator, Zagazig University Radiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446116
- Sponsor's protocol ID
- Zu-IRB#9027/13-6-2021
- Status last verified
- Jun 2022
- First submitted
- 19 Oct 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05446116
- Acronym / sponsor ID
- Zu-IRB#9027/13-6-2021
- Conditions
- Hypersplenism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 6 Jul 2022 (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.
The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.
Detailed description
Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications.
PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoral puncture | Active comparator | Procedure: partial splenic artery embolizationUnder local anaesthesia, the femoral artery was punctured and 6F sheath was inserted. Splenic artery was catheterized using 4- or 5-F catheters (Cobra C2 cat or Simmons II catheter Imager-Boston Scientific Natick, Massachusetts). Embolization was done using Embospheres (Biosphere Medical, Rockland, MA) 700-900 μ in diameter. |
| Radial puncture | Active comparator | Procedure: partial splenic artery embolizationThe left radial artery was preferred due to shorter distance from the left wrist to the splenic artery in comparison to the right wrist; also the left radial access theoretically decreases the risk of cerebral emboli. Under local anaesthesia and ultrasound guidance, the radial artery was punctured and 5- or 6-F sheath was introduced. After sheath insertion, the radial cocktail (2.5 mg of verapamil, 100 μg of nitroglycerin, and 5,000 units of heparin) was injected through the sheath over one minute after dilution with 20 ml of blood to decrease the discomfort during injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hypersplenism and severe thrombocytopenia (platelet count < 50,000/mm3).
- the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR < 1.7, no ascites, no encephalopathy).
- Eligible for both femoral and radial puncture.
Key exclusion criteria (2 listed)
- Patients referred for embolization as treatment of traumatic splenic injury.
- Patients lost during follow-up.
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 |
|---|---|---|
| partial splenic artery embolizationembolization of the splenic artery for the treatment of hypersplenism | Procedure or surgery | Radial puncture, femoral puncture |
Primary outcome
Technical Success of the Procedure
Time frame: Immediately after the procedure is complete
The achievement of a single puncture allowing access to splenic artery without periprocedural complications.
Average number of punctures
Time frame: Immediately after the procedure is complete
Number of arterial punctures required to complete the procedure
Procedural time
Time frame: Immediately after the procedure is complete
The time interval from starting the anaethesia till completion of the procedure
X-ray exposure duration
Time frame: Immediately after the procedure is complete
Duration of flouroscopy exposure during the procedure
Length of hospital stay
Time frame: 7 days
Number of days that the patient will spend in the hospital after the procedure.
Complications at access site
Time frame: 30 days
Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding.
1 secondary outcome
Procedural complications
Time frame: 30 days
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 6 Jul 2022.
- 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 MA Zaitoun, MD principal investigator
Zagazig University Radiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial splenic artery embolization in people with Hypersplenism, run by Zagazig University at 1 site in Egypt.
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 3 inclusion and 2 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 6 Jul 2022. 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 Egypt. 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?
Technical Success of the Procedure (time frame: Immediately after the procedure is complete). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2022.