Radial Artery OcclusionDEFINITIONNCT04561648
Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
A study testing Unfractionated Heparin in people with Radial Artery Occlusion, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- Unfractionated Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,988 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2020to 1 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age, both genders.
- Successful transradial acess for an elective diagnostic coronary angiography.
Who cannot join
- Weight <50 Kg
- Puncture of the ipsilateral radial artery in the last month.
- Still ongoing effect of pre-procedural recently used oral anticoagulants.
- Use of enoxaparin in the past in the last 12 hours prior to the procedure.
- Use of unfractionated heparin in the last 6 hours prior the procedure
- Alterations in coagulation or platelets prone to bleeding or thrombotic complications.
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- Anatomical alterations at the radial access site or radial artery.
- Arteriovenous fistula in the ipsilateral arm.
- History of major bleeding associated with the use of UFH.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Tlalpan, 14080
Monserrat Villalobos, M.D., 55 5573 2911 ext. 21217, movspa@hotmail.com
Guering Edit Lid, M.D., 55 5573 2911 ext. 21217, guering@yahoo.com
About this study
Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.
Read the detailed description
Radial artery occlusion (RAO) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure.
Currently worldwide, the transradial (TRA) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access).
Although TRA access is safer, it is not free of complications, being one of the most important the RAO.
There are universal efforts to reduce RAO improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal TRA, with evidence suggesting that higher doses of UFH can also decrease RAO to a greater extent. The decrease in the incidence of RAO have been proposed to be up to 2.8 times with high doses of UFH (single-center, retrospective study that compared regular not standard doses of UFH versus higher doses of UFH) although no proper prospective clinical trial have been undertaken to prove this.
The standard dose that has shown a lower rate of RAO is 5000 IU, which will be compared with 100 IU / Kg of UFH, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with Doppler ultrasound (DUS) and its correlation with plethysmography to document RAO, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by DUS (and plethysmography). In order to address safety concerns of higher UFH doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.
- Conditions
- Radial Artery Occlusion
- Being tested
- Unfractionated Heparin
- Keywords
- Radial Artery Occlusion, Percutaneous coronary intervention, Transradial access, Unfractionated Heparin, Coronary angiography
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated HeparinDrug
Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
| Study group | Role | What they receive |
|---|---|---|
| High Dose of Unfractionated Heparin | Experimental | 100 IU/Kg of Unfractionated Heparin Receives: Drug: Unfractionated Heparin |
| Standard Dose of Unfractionated Heparin | Active comparator | 5000 IU of Unfractionated Heparin. Receives: Drug: Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion (RAO).
The incidence of RAO (with DUS and plethysmography).
Measured: 24 hours.
Radial artery occlusion (RAO).
The incidence of RAO (with DUS and plethysmography).
Measured: 30 days.
Secondary outcomes (5)
Time to hemostasis.
Time to hemostasis, from the removal of the introducer sheath to hemostasis.
Measured: 24 hours.
Diameters of the radial artery.
Minimum, maximum and mean diameters of the radial artery by vascular ultrasound.
Measured: 24 hours.
Correlation of RAO by oximetric plethysmography and DUS.
Correlation of plethysmography and DUS for the determination of RAO.
Measured: 30 days.
Hemorrhagic Complications.
Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale:
The BARC-2 scale:
- Type 0
- Type 1
- Type 2
- Type 3
- Type 4
- Type 5
Measured: 30 days.
Hemorrhagic Complications.
Compare the incidence of bleeding complications according to the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) scale:
The EASY scale:
- Grade I
- Grade II
- Grade III
- Grade IV
- Grade V
Measured: 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Patients that are planned to go to an invasive coronary artery angiography with good radial pulse and using the TRA are going to be randomized to two groups. One will receive the standard UFH dose and the other will receive the prespecified high dose (per Kg of body weight) of UFH.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,988 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Ivan Farjat Pasos, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Guering Eid Lidt, M.D., Study director, Instituto Nacional de Cardiología Ignacio ChávezJulio I Farjat Pasos, M.D., Principal investigator, Instituto Nacional de Cardiología Ignacio ChávezCarlos Aguila Bravo, M.D., Principal investigator, Instituto Nacional de Cardiología Ignacio ChávezMonserrat Villalobos Pedroza, M.D., Principal investigator, Instituto Nacional de Cardiología Ignacio Chávez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561648
- Sponsor's protocol ID
- INCAR-DG-DI-205-2020
- Acronym
- DEFINITION
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual patient data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
- ClinicalTrials.gov ID
- NCT04561648
- Acronym / sponsor ID
- DEFINITION / INCAR-DG-DI-205-2020
- Conditions
- Radial Artery Occlusion
- Keywords
- Radial Artery Occlusion, Percutaneous coronary intervention, Transradial access, Unfractionated Heparin, Coronary angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,988 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 23 Sep 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.
Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.
Detailed description
Radial artery occlusion (RAO) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure.
Currently worldwide, the transradial (TRA) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access).
Although TRA access is safer, it is not free of complications, being one of the most important the RAO.
There are universal efforts to reduce RAO improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal TRA, with evidence suggesting that higher doses of UFH can also decrease RAO to a greater extent. The decrease in the incidence of RAO have been proposed to be up to 2.8 times with high doses of UFH (single-center, retrospective study that compared regular not standard doses of UFH versus higher doses of UFH) although no proper prospective clinical trial have been undertaken to prove this.
The standard dose that has shown a lower rate of RAO is 5000 IU, which will be compared with 100 IU / Kg of UFH, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with Doppler ultrasound (DUS) and its correlation with plethysmography to document RAO, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by DUS (and plethysmography). In order to address safety concerns of higher UFH doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients that are planned to go to an invasive coronary artery angiography with good radial pulse and using the TRA are going to be randomized to two groups. One will receive the standard UFH dose and the other will receive the prespecified high dose (per Kg of body weight) of UFH.
| Arm | Type | Receives |
|---|---|---|
| High Dose of Unfractionated Heparin | Experimental | Drug: Unfractionated Heparin100 IU/Kg of Unfractionated Heparin |
| Standard Dose of Unfractionated Heparin | Active comparator | Drug: Unfractionated Heparin5000 IU of Unfractionated Heparin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age, both genders.
- Successful transradial acess for an elective diagnostic coronary angiography.
Key exclusion criteria (9 listed)
- Weight <50 Kg
- Puncture of the ipsilateral radial artery in the last month.
- Still ongoing effect of pre-procedural recently used oral anticoagulants.
- Use of enoxaparin in the past in the last 12 hours prior to the procedure.
- Use of unfractionated heparin in the last 6 hours prior the procedure
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 |
|---|---|---|
| Unfractionated HeparinBefore removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin. | Drug | High Dose of Unfractionated Heparin, Standard Dose of Unfractionated Heparin |
Primary outcome
Radial artery occlusion (RAO).
Time frame: 24 hours.
The incidence of RAO (with DUS and plethysmography).
Radial artery occlusion (RAO).
Time frame: 30 days.
The incidence of RAO (with DUS and plethysmography).
5 secondary outcomes
Time to hemostasis.
Time frame: 24 hours.
Diameters of the radial artery.
Time frame: 24 hours.
Correlation of RAO by oximetric plethysmography and DUS.
Time frame: 30 days.
Hemorrhagic Complications.
Time frame: 30 days.
Hemorrhagic Complications.
Time frame: 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No. The individual patient data will not be shared with other researchers.
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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.
Guering Eid Lidt, M.D. study director
Instituto Nacional de Cardiología Ignacio Chávez
Julio I Farjat Pasos, M.D. principal investigator
Instituto Nacional de Cardiología Ignacio Chávez
Carlos Aguila Bravo, M.D. principal investigator
Instituto Nacional de Cardiología Ignacio Chávez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unfractionated Heparin in people with Radial Artery Occlusion, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 9 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monserrat Villalobos Pedroza, M.D. (55 5573 2911 ext. 21217, movspa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (RAO). (time frame: 24 hours.). The study lists 2 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 20 Feb 2024.