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

Phase 1

Recruiting

• Conditions: D019106; Postoperative hemorrhage; transfemoral artery approach, endovascular theraphy, bed rest time

• Registration Number: JPRN-jRCT1052220199
• Lead Sponsor: Okada Takuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified