Vascular Access ComplicationSAMOVARNCT02069275
Immediate Mobilization After Cardiac Catheterisation
A study testing Immediate mobilization and Two hours bedrest in people with Vascular Access Complication and Comfort, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Comfort
- What is being tested?
- Immediate mobilization and Two hours bedrest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Dec 2016
- 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
- CAG or PCI performed via the femoral artery
- No hematoma in the groin (> 5 cm in diameter)
- Heparin reversed with protamine after PCI
Who cannot join
- Oozing, bleeding or hematoma
- Treatment with Integrilin, ReoPro, or Marevan
- Heparin can not be reversed
- The patient does not want to participate
- Systolic blood pressure > 180 mm Hg after the procedure
- BMI> 35 (can be modified if the groin can be assessed in an upright position)
- Demented, unconscious patients who do not understand the information for participants.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen, DK-2100
Marianne W Noergaard, MVO, +45 35458869, marianne.wetendorff.noergaard@regionh.dk
Jane Faerch, MSc, +45 35452767, jane.faerch.@regionh.dk
About this study
Official title: Patients Immediate Mobilization After Coronary Angiography and Percutaneous Coronary Intervention. Is it SAfe to MObilize Patients Very eARly After Cardiac Catheterisation?
The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.
Read the detailed description
The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime.
There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI.
- Conditions
- Vascular Access Complication, Comfort
- Being tested
- Immediate mobilization, Two hours bedrest
- Keywords
- Immediate mobilization, Bedrest, Coronary angiography, Coronary percutaneous intervention, Vascular access complications, Patients comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate mobilizationOther
Patients are mobilized immediate after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device. Heparin reverted with Protaminsulphate
Two hours bedrestOther
Patients is following the usual regimen, two hours bedrest after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device before mobilization. Heparin is reverted with Protaminsulphate
| Study group | Role | What they receive |
|---|---|---|
| Immediate mobilization | Experimental | Immediate mobilization after coronary angiography or percutaneous coronary intervention Receives: Other: Immediate mobilization |
| Two hours bedrest | Active comparator | Bedrest two hours after coronary angiography or percutaneous coronary intervention Receives: Other: Two hours bedrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma> 5 cm
occurred after the end of the procedure, including retroperitoneal hematoma, bleeding requiring transfusion or pseudoaneurysm that require vascular surgical intervention. Assessed after 30 minutes, after two hours and before discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Secondary outcomes (4)
The presence of hematoma> 10 cm in diameter
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 hours
The presence of hematoma 2-5 cm in diameter
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Oozing or bleeding from the puncture site
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Comfort rating (NRS scale)
Measured: Two hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Wetendorff Noergaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Marianne W Moergaard, MVO, Principal investigator, Cardiac Cath.lab. Copenhagen University Hospital, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069275
- Sponsor's protocol ID
- SAMOVAR 01
- Acronym
- SAMOVAR
- Status last verified
- Jun 2016
- First submitted
- 13 Feb 2014
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Norgaard MW, Faerch J, Joshi FR, Hofsten DE, Engstrom T, Kelbaek H. Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR): A Randomized Clinical Trial. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):E114-E121. doi: 10.1097/JCN.0000000000000845. Epub 2021 Jul 26.
PubMed 34321432
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Immediate Mobilization After Coronary Angiography and Percutaneous Coronary Intervention. Is it SAfe to MObilize Patients Very eARly After Cardiac Catheterisation?
- ClinicalTrials.gov ID
- NCT02069275
- Acronym / sponsor ID
- SAMOVAR / SAMOVAR 01
- Conditions
- Vascular Access Complication, Comfort
- Keywords
- Immediate mobilization, Bedrest, Coronary angiography, Coronary percutaneous intervention, Vascular access complications, Patients comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Feb 2014 (estimated)
- 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 purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.
Detailed description
The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime.
There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate mobilization | Experimental | Other: Immediate mobilizationImmediate mobilization after coronary angiography or percutaneous coronary intervention |
| Two hours bedrest | Active comparator | Other: Two hours bedrestBedrest two hours after coronary angiography or percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CAG or PCI performed via the femoral artery
- No hematoma in the groin (> 5 cm in diameter)
- Heparin reversed with protamine after PCI
Key exclusion criteria (7 listed)
- Oozing, bleeding or hematoma
- Treatment with Integrilin, ReoPro, or Marevan
- Heparin can not be reversed
- The patient does not want to participate
- Systolic blood pressure > 180 mm Hg after 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 |
|---|---|---|
| Immediate mobilizationPatients are mobilized immediate after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device. Heparin reverted with Protaminsulphate | Other | Immediate mobilization |
| Two hours bedrestPatients is following the usual regimen, two hours bedrest after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device before mobilization. Heparin is reverted with Protaminsulphate | Other | Two hours bedrest |
Primary outcome
Hematoma> 5 cm
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
occurred after the end of the procedure, including retroperitoneal hematoma, bleeding requiring transfusion or pseudoaneurysm that require vascular surgical intervention. Assessed after 30 minutes, after two hours and before discharge
4 secondary outcomes
The presence of hematoma> 10 cm in diameter
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
The presence of hematoma 2-5 cm in diameter
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Oozing or bleeding from the puncture site
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Comfort rating (NRS scale)
Time frame: Two hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Derived from this study: PubMed 34321432Norgaard MW, Faerch J, Joshi FR, Hofsten DE, Engstrom T, Kelbaek H. Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR): A Randomized Clinical Trial. J Cardiovasc Nurs. 2022 Sep-Oct 01;37(5):E114-E121. doi: 10.1097/JCN.0000000000000845. Epub 2021 Jul 26.
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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.
Marianne W Moergaard, MVO principal investigator
Cardiac Cath.lab. Copenhagen University Hospital, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate mobilization and Two hours bedrest in people with Vascular Access Complication and Comfort, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 1 Jul 2016. 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 Denmark. 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 Marianne W Noergaard, MVO (+45 35458869, marianne.wetendorff.noergaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma> 5 cm (time frame: participants will be followed for the duration of hospital stay, an expected average of 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 NCT02069275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.