Radial Artery OcclusionNCT04380883
Combination of InnoSEAL Plus TR Band Compared to TR Band Alone
A study testing InnoSEAL+TRB and TRB alone in people with Radial Artery Occlusion and Hematoma, run by Tabba Heart Institute at 1 site in Pakistan.
Trial summary
Angiography or angioplasty are commonly now done through inserting the device through radial artery in hand i.e. trans-radial procedures. It is reported that between 2-30% of these procedures get complicated by radial artery occlusion (RAO) which limit future use of this site for similar procedures if needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion, Hematoma
- What is being tested?
- InnoSEAL+TRB and TRB alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 714 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2020to 30 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of both gender undergoing coronary procedure using trans radial approach (diagnostic or PCI) will be included
- Both elective and hemodynamically stable, acute coronary syndrome (ACS) patients will be included.
Who cannot join
- Sheath larger than 6F
- IV Heparin or GP 2b/3a inhibitors continued after the procedure
- Ongoing anticoagulation with Warfarin or Rivaroxaban or INR > 3
- Ipsilateral AV fistula
- Barbeau's Class D
- History of RAO at baseline
- Patients unable to give consent due to clinical instability or sedation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of InnoSEAL Plus TR Band Compared to TR Band Alone for Radial Artery Outcomes in Patients Undergoing Transradial Coronary Intervention (InnoSEAL II)
Angiography or angioplasty are commonly now done through inserting the device through radial artery in hand i.e. trans-radial procedures. It is reported that between 2-30% of these procedures get complicated by radial artery occlusion (RAO) which limit future use of this site for similar procedures if needed. It is important to control the arterial bleeding after the procedure completion while maintaining radial arterial flow appears to be an important factor in reducing RAO (patent hemostasis). Currently the most frequently employed method for hemostasis following trans-radial procedures is a compression device (RCD) such as TransRadial Bands (TRB). But TRB takes hours to achieve hemostasis and causes discomfort to the patients and longer time to discharge. Hemostatic pads offer an alternative to RCD where overall compression time is inherently low and patent hemostasis can possibly be achieved. The combined use of TR band with a hemostatic device may allow ease of use with reduced hemostasis time.
The trial aims to test the hypothesis that compared to TR band (TRB) alone, catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.) used in conjunction with TRB (InnoSEAL+TRB)is nearly as good as TRB alone in terms of the outcomes like RAO and hematoma.
Read the detailed description
It is a prospective, randomized, open label trial with the following study hypotheses (Ha):
- InnoSEAL+TRB is non-inferior to TRB alone in terms of the composite adverse access site outcomes including RAO and hematoma.
- InnoSEAL+TRBis non-inferior to TRB alone when comparing ease of use scores rated by the cath lab technicians.
- InnoSEAL+TRB is superior to TRB alone for outcomes of reduction in total hemostasis time, total observation time for the radial site and time to hospital discharge for daycare patients sub group.
- InnoSEAL+TRBis superior to TRB alone in terms of minimized patient discomfort.
Sample size:
Keeping a combined complication rate of 17.7% (RAO:7.7%, Hematoma: 10%), difference in favor of the experimental treatment of 4.89%, power of 80%, one sided alpha of 2.5%, 10% attrition rate, a sample of at least 357 patients in each group and a total of 714 patients will be required.
Randomization:
Randomization will be performed using variable sized blocks through computer software by an unrelated staff from the research department who is not a part of this study and will be kept in safe in the research department. Allocation of intervention will be informed to the research staff for each individual patient through telephone call, only after the informed consent has been taken by the data collector.
Intervention arm:
In InnoSEAL+TRB arm, InnoSEAL patch will be applied at the puncture site and will be covered by a transparent dressing. TRB will be applied over the patch and 12 cc air will be injected to inflate the band. Air is removed from TRB during 60 minutes, removing 2cc air at 20 minutes, 4cc at 40 minutes and 6cc at 60 minutes from the time of sheath removal.
Control arm:
TR band is applied centered over the puncture site and the bladder is inflated with 15cc air. Air is removed gradually leaving at least 10 cc air provided there is no oozing. Start removing air at 90 min (from the time of hemostasis protocol):
4cc-at 20 min, 6cc-at 40 min. 6cc-at each 20 min till reach 0cc. If re-bleeding at any time, reintroduce 2cc air.
In both the arms TRB will be left with 0cc air for 30 min. Reverse Barbeau's test will be applied in both the arms to determine RAO. If occlusion was found, radial artery ultrasound will be conducted. Both TRB and InnoSEAL patch will be removed before discharge of the patient.
Data quality measures:
Data will be collected by the trained nursing staff hired specifically for the study and who will receive one day training on study protocols. Study coordinator will daily check all the forms for completeness and accuracy and 10% of the completed forms will be randomly checked by one of the study investigators. Institutional IRB will also do an audit of the study procedures.
Data entry and analysis:
Data will be entered in Access data base and will be analyzed through SPSS v.25. Means and standard deviation will be reported for continuous data based on normality assumption along with histograms and compared using Student t-test. And frequencies with percentages will be reported for the categorical variables. The differences between categorical variables were examined by the Chi square test considering p-value< .05 statistically significant. Chi square test will be utilized to assess primary composite outcome and its components. Independent sample t-test will be used for comparison of time intervals. Kruskall Wallis test will be utilized for significance testing between ordinal secondary outcomes of ease of use and patient discomfort.
- Conditions
- Radial Artery Occlusion, Hematoma
- Being tested
- InnoSEAL+TRB, TRB alone
- Keywords
- radial artery occlusion, access site outcomes, hemostatic patch
- Medical subject headings
- Arterial Occlusive Diseases, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoSEAL+TRBDevice
InnoSEAL is a catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.). Chitosan-Catechol in InnoSEAL instantly forms an adhesive barrier upon blood contact. It is intended for use under the care of a healthcare professional. The dressing is indicated for the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes. TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. We will apply InnoSEAL and TRB together.
TRB aloneDevice
TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. It will be the comparing arm.
| Study group | Role | What they receive |
|---|---|---|
| InnoSEAL+TRB | Experimental | InnoSEAL is a hemostatic patch which will be applied along with TRB to control bleeding from access site Receives: Device: InnoSEAL+TRB |
| TRB alone | Active comparator | Not described Receives: Device: TRB alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Access site combined outcomes
Proportion of patients with RAO and/or hematoma of any grade.
- Radial artery occlusion: Radial artery will be defined as occluded if reverse Barbeau's test shows absence of flow on pulse oximetry just after the removal of the TR band in both groups.In patients identified to have RAO, findings will be confirmed using UltraSound (US) Duplex using color flow with pulse wave imaging within 24 hours of the radial procedure.US Duplex will be performed during the index hospital stay.
- Radial Hematoma: Radial artery site will be assessed for presence of hematoma at the end of hemostasis protocol. Hematoma will be marked if present, and graded according to categories of I-IV. Hematomas grade II-IV will be considered significant.
Measured: within 24 hours
Secondary outcomes (5)
Ease of use
Ease of use of InnoSEAL will be assessed by a system usability scale (SUS), 5 point Likert scale by the cath lab personnel who routinely perform post procedure hemostasis. Ease of use is reported as percentage acceptability where 100% means highly acceptable and vice versa. Ease of use proforma will be filled by the participating cath lab staffs at the end of the study.
Measured: Upto 30 weeks
Total compression time:
Time required from radial sheath removal to the removal of all the air from TR band.
Measured: within 24 hours
Total observation time:
Time required from radial sheath removal to the removal of TR band (included time for observation at 0 cc for safety purpose).
Measured: within 24 hours
Time to hospital discharge: (For daycare patients only)
Time from removal of radial sheath till patient discharge from hospital
Measured: within 24 hours
Patient discomfort:
Standard visual pain scale of 1-10 will be utilized. Pain will be assessed after the hemostasis protocol is ended.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start3 Jun 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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 Radial Artery OcclusionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabba Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380883
- Sponsor's protocol ID
- InnoSEAL II
- Status last verified
- Oct 2022
- First submitted
- 4 May 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aijaz S, Sheikh S, Pathan A. Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol). BMJ Open. 2020 Dec 23;10(12):e042101. doi: 10.1136/bmjopen-2020-042101.
PubMed 33361166
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of InnoSEAL Plus TR Band Compared to TR Band Alone for Radial Artery Outcomes in Patients Undergoing Transradial Coronary Intervention (InnoSEAL II)
- ClinicalTrials.gov ID
- NCT04380883
- Acronym / sponsor ID
- InnoSEAL II
- Conditions
- Radial Artery Occlusion, Hematoma
- Keywords
- radial artery occlusion, access site outcomes, hemostatic patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- Tabba Heart InstituteUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 8 May 2020 (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.
Angiography or angioplasty are commonly now done through inserting the device through radial artery in hand i.e. trans-radial procedures. It is reported that between 2-30% of these procedures get complicated by radial artery occlusion (RAO) which limit future use of this site for similar procedures if needed. It is important to control the arterial bleeding after the procedure completion while maintaining radial arterial flow appears to be an important factor in reducing RAO (patent hemostasis). Currently the most frequently employed method for hemostasis following trans-radial procedures is a compression device (RCD) such as TransRadial Bands (TRB). But TRB takes hours to achieve hemostasis and causes discomfort to the patients and longer time to discharge. Hemostatic pads offer an alternative to RCD where overall compression time is inherently low and patent hemostasis can possibly be achieved. The combined use of TR band with a hemostatic device may allow ease of use with reduced hemostasis time.
The trial aims to test the hypothesis that compared to TR band (TRB) alone, catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.) used in conjunction with TRB (InnoSEAL+TRB)is nearly as good as TRB alone in terms of the outcomes like RAO and hematoma.
Detailed description
It is a prospective, randomized, open label trial with the following study hypotheses (Ha):
- InnoSEAL+TRB is non-inferior to TRB alone in terms of the composite adverse access site outcomes including RAO and hematoma.
- InnoSEAL+TRBis non-inferior to TRB alone when comparing ease of use scores rated by the cath lab technicians.
- InnoSEAL+TRB is superior to TRB alone for outcomes of reduction in total hemostasis time, total observation time for the radial site and time to hospital discharge for daycare patients sub group.
- InnoSEAL+TRBis superior to TRB alone in terms of minimized patient discomfort.
Sample size:
Keeping a combined complication rate of 17.7% (RAO:7.7%, Hematoma: 10%), difference in favor of the experimental treatment of 4.89%, power of 80%, one sided alpha of 2.5%, 10% attrition rate, a sample of at least 357 patients in each group and a total of 714 patients will be required.
Randomization:
Randomization will be performed using variable sized blocks through computer software by an unrelated staff from the research department who is not a part of this study and will be kept in safe in the research department. Allocation of intervention will be informed to the research staff for each individual patient through telephone call, only after the informed consent has been taken by the data collector.
Intervention arm:
In InnoSEAL+TRB arm, InnoSEAL patch will be applied at the puncture site and will be covered by a transparent dressing. TRB will be applied over the patch and 12 cc air will be injected to inflate the band. Air is removed from TRB during 60 minutes, removing 2cc air at 20 minutes, 4cc at 40 minutes and 6cc at 60 minutes from the time of sheath removal.
Control arm:
TR band is applied centered over the puncture site and the bladder is inflated with 15cc air. Air is removed gradually leaving at least 10 cc air provided there is no oozing. Start removing air at 90 min (from the time of hemostasis protocol):
4cc-at 20 min, 6cc-at 40 min. 6cc-at each 20 min till reach 0cc. If re-bleeding at any time, reintroduce 2cc air.
In both the arms TRB will be left with 0cc air for 30 min. Reverse Barbeau's test will be applied in both the arms to determine RAO. If occlusion was found, radial artery ultrasound will be conducted. Both TRB and InnoSEAL patch will be removed before discharge of the patient.
Data quality measures:
Data will be collected by the trained nursing staff hired specifically for the study and who will receive one day training on study protocols. Study coordinator will daily check all the forms for completeness and accuracy and 10% of the completed forms will be randomly checked by one of the study investigators. Institutional IRB will also do an audit of the study procedures.
Data entry and analysis:
Data will be entered in Access data base and will be analyzed through SPSS v.25. Means and standard deviation will be reported for continuous data based on normality assumption along with histograms and compared using Student t-test. And frequencies with percentages will be reported for the categorical variables. The differences between categorical variables were examined by the Chi square test considering p-value< .05 statistically significant. Chi square test will be utilized to assess primary composite outcome and its components. Independent sample t-test will be used for comparison of time intervals. Kruskall Wallis test will be utilized for significance testing between ordinal secondary outcomes of ease of use and patient discomfort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InnoSEAL+TRB | Experimental | Device: InnoSEAL+TRBInnoSEAL is a hemostatic patch which will be applied along with TRB to control bleeding from access site |
| TRB alone | Active comparator | Device: TRB alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients of both gender undergoing coronary procedure using trans radial approach (diagnostic or PCI) will be included
- Both elective and hemodynamically stable, acute coronary syndrome (ACS) patients will be included.
Key exclusion criteria (7 listed)
- Sheath larger than 6F
- IV Heparin or GP 2b/3a inhibitors continued after the procedure
- Ongoing anticoagulation with Warfarin or Rivaroxaban or INR > 3
- Ipsilateral AV fistula
- Barbeau's Class D
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 |
|---|---|---|
| InnoSEAL+TRBInnoSEAL is a catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.). Chitosan-Catechol in InnoSEAL instantly forms an adhesive barrier upon blood contact. It is intended for use under the care of a healthcare professional. The dressing is indicated for the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes. TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. We will apply InnoSEAL and TRB together. | Device | InnoSEAL+TRB |
| TRB aloneTRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. It will be the comparing arm. | Device | TRB alone |
Primary outcome
Proportion of patients with Access site combined outcomes
Time frame: within 24 hours
Proportion of patients with RAO and/or hematoma of any grade. 1. Radial artery occlusion: Radial artery will be defined as occluded if reverse Barbeau's test shows absence of flow on pulse oximetry just after the removal of the TR band in both groups.In patients identified to have RAO, findings will be confirmed using UltraSound (US) Duplex using color flow with pulse wave imaging within 24 hours of the radial procedure.US Duplex will be performed during the index hospital stay. 2. Radial Hematoma: Radial artery site will be assessed for presence of hematoma at the end of hemostasis protocol. Hematoma will be marked if present, and graded according to categories of I-IV. Hematomas grade II-IV will be considered significant.
5 secondary outcomes
Ease of use
Time frame: Upto 30 weeks
Total compression time:
Time frame: within 24 hours
Total observation time:
Time frame: within 24 hours
Time to hospital discharge: (For daycare patients only)
Time frame: within 24 hours
Patient discomfort:
Time frame: within 24 hours
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 20 Oct 2022.
- Derived from this study: PubMed 33361166Aijaz S, Sheikh S, Pathan A. Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol). BMJ Open. 2020 Dec 23;10(12):e042101. doi: 10.1136/bmjopen-2020-042101.
Related trials for Radial Artery Occlusion
Not yet recruitingPhase 4
SPARK Study - Sympathetic Periarterial Radial Block in Healthy Volunteers
Healthy Volunteers, Sympathetic Activity
Recruiting
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Vascular Access Site Occlusion
Recruiting
Randomization of Single vs Multiple Arterial Grafts
Coronary Artery Disease, Heart Diseases
RecruitingObservational study
Radial Access Data in Vascular Interventions Registry
Radial Artery Occlusion, Radial Artery Spasm
Recruiting
Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
Coronary Angiography, Percutaneous Coronary Intervention
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnoSEAL+TRB and TRB alone in people with Radial Artery Occlusion and Hematoma, run by Tabba Heart Institute at 1 site in Pakistan.
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 2 inclusion and 7 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 20 Oct 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 Pakistan. 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?
Proportion of patients with Access site combined outcomes (time frame: within 24 hours). 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 NCT04380883, 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 20 Oct 2022.