Exploratory research to shorten bed rest time after catheter treatment by femoral artery using a groin compression device (Rebelt)

JRCT ID: jRCT1052220199

Registered date:20/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postoperative hemorrhage
• Date of first enrollment: 20/03/2023
• Target sample size: 200
• Study type: Interventional
• Intervention(s): After catheter therapy or angiography via the transfemoral artery approach, continuous compression hemostasis is performed with a groin compression device to reduce the bed rest time compared to conventional techniques

Outcome(s)

• Primary Outcome: Presence/absence of hemorrhagic adverse events

Secondary Outcome

Presence/absence of non-hemorrhagic adverse events
Presence/absence of minor bleeding adverse events
Presence/absence of physical and mental distress

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who perform catheter therapy or angiography via trans-femoral artery approach and fulfill the following;
1) A 4 or 5Fr. sheath is used.
2) Temporary hemostasis is achieved without abnormality by manual compression at the time of sheath removal.
3) Compression is started using a rebelt after temporary hemostasis.
2. The patient is at least 18 years of age at the time consent is obtained.
3. Written consent for participation in this clinical research has been obtained from the patient.

Exclude criteria

1. Patients taking two or more antiplatelet or anticoagulant drugs and unable to discontinue medications or reduce dose to aspirin only prior to the procedure.
2. Patients with high bleeding risk (platelet count < 50,000, PT-INR >= 1.5).
3. Intraoperative use of heparin and ACT at the time of sheath removal is >180 seconds or not measured.
4. There are pain, a surgical wound, hernia, or other abnormality at the planned puncture site.
5. Inability to maintain supine rest after procedure.
6. Difficulty in communicating.
7. Other patients deemed inappropriate as research subjects by the investigators.

Related Information

• Primary Sponsor: Gentsu Tomoyuki