Trial Outcomes & Findings for Heart and Hands Study II: A Retrospective Data Collection & Analysis Project (NCT NCT02307318)

Last Updated: 2017-01-11

Results Overview

Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Day1

Results posted on

2017-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	SoftSeal Hemostatic Pad This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart and Hands Study II: A Retrospective Data Collection & Analysis Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SoftSeal Hemostatic Pad n=51 Participants This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
Age, Continuous	61.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Gender Female	22 Participants n=5 Participants
Gender Male	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: Day1

Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.

Outcome measures

Outcome measures
Measure	SoftSeal Hemostatic Pad n=51 Participants This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
Incidence of Arterial Bleeding	1 Participants

PRIMARY outcome

Timeframe: 4 hours post-surgery

Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.

Outcome measures

Outcome measures
Measure	SoftSeal Hemostatic Pad n=51 Participants This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
Incidence of Thrombosis	0 Participants

SECONDARY outcome

Timeframe: Day1

Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.

Outcome measures

Outcome measures
Measure	SoftSeal Hemostatic Pad n=51 Participants This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
Changes in Circulation, Movement and Sensation	0 Participants

SECONDARY outcome

Timeframe: Day1

Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.

Outcome measures

Outcome measures
Measure	SoftSeal Hemostatic Pad n=51 Participants This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
Incidence of Hematoma and/or Ecchymosis	0 Participants

Adverse Events

SoftSeal Hemostatic Pad

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Fehrer

HealthEast Care System

Phone: 651-232-5363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place