Clinical trial NCT02069275: Immediate Mobilization After Cardiac Catheterisation
Official title: Patients Immediate Mobilization After Coronary Angiography and Percutaneous Coronary Intervention. Is it SAfe to MObilize Patients Very eARly After Cardiac Catheterisation?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Complication
Comfort
Keywords: Immediate mobilization
Bedrest
Coronary angiography
Coronary percutaneous intervention
Vascular access complications
Patients comfort
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* CAG or PCI performed via the femoral artery
* No hematoma in the groin (\> 5 cm in diameter)
* Heparin reversed with protamine after PCI

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hematoma> 5 cm
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Secondary outcomes:
measure: The presence of hematoma> 10 cm in diameter
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: The presence of hematoma 2-5 cm in diameter
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Oozing or bleeding from the puncture site
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Comfort rating (NRS scale)
timeFrame: Two hours after the procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Cardiac Cath.lab. Copenhagen University Hospital, Rigshospitalet, Denmark
name: Marianne W Moergaard, MVO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.