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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52480

Enrollment

250

Registered

2020-11-16

Start date

2021-02-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand function disorders peripheral neuropathy

Interventions

After trans radial catheter access, we will compare conventional hemostasis by 2 full hours of applied pressure by the vascular closure device to combined hemostasis using Statseal Advanced Disc app

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Previous TRA through the same radial artery - Previous upper limb surgery

Design outcomes

Primary

Measure	Time frame
The occurrence of diminished hand sensibility after TRA as measured by the Semmes-Weinstein monofilaments score before and 1 month after intervention.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)