Conventional vascular closure device vs Statseal hemostasis: Comparing the effects on hand sensibility for radial hemostasis

Completed

• Conditions: Hand function disorders; peripheral neuropathy; 10001316; 10034606; 10007593

• Registration Number: NL-OMON52480
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

- Patients admitted for trans radial access coronary angiography
- Older than 18 years
- Able and willing to give informed consent.

Exclusion Criteria

- Previous TRA through the same radial artery
- Previous upper limb surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The occurrence of diminished hand sensibility after TRA as measured by the<br /><br>Semmes-Weinstein monofilaments score before and 1 month after intervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Perceived hand function disorders as measured in the The Disabilities of the<br /><br>Arm, Shoulder and Hand Score (Quick DASH score ) and Cold Intolerance Symptom<br /><br>Severity score (CISS score) before and 1 month after intervention.<br /><br>- Objectified hand strength disorders as measured in the pinch and manual grip<br /><br>(PMG) tests.<br /><br>- Bleeding complications as defined as any blood loss from the trans radial<br /><br>access site after hemostasis which requires additional usage of vascular<br /><br>closure device.</p><br>