Trial Outcomes & Findings for The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery (NCT NCT01605019)

Results Overview

The Primary Objective of this prospective pilot study is to evaluate the use of CoSeal™ for its ability to reduce bleeding following the implantation of a LVAD. Total output amounts for each chest tube (CT) will be collected every 24 hours until all chest tubes are discontinued. Additionally, the total number of blood transfusions required during the hospitalization to implant the LVAD will be collected

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks.

Results posted on

2018-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	CoSeal Arm patient randomized to received Coseal during LVAD implantation CoSeal: 3 - 8mls of Coseal	BioGlue® Surgical Adhesive BioGlue® Surgical Adhesive or use of no sealant application BioGlue® Surgical Adhesive: Total amount applied - 8 mls
Overall Study STARTED	4	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CoSeal Arm patient randomized to received Coseal during LVAD implantation CoSeal: 3 - 8mls of Coseal	BioGlue® Surgical Adhesive BioGlue® Surgical Adhesive or use of no sealant application BioGlue® Surgical Adhesive: Total amount applied - 8 mls
Overall Study pt did not meet transplant endpoint	3	0

Baseline Characteristics

The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks.

Population: no analysis was performed on the 4 subjects enrolled in the study - they did not complete study.

The Primary Objective of this prospective pilot study is to evaluate the use of CoSeal™ for its ability to reduce bleeding following the implantation of a LVAD. Total output amounts for each chest tube (CT) will be collected every 24 hours until all chest tubes are discontinued. Additionally, the total number of blood transfusions required during the hospitalization to implant the LVAD will be collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for duration of hospital stay, typically average of 1-4 weeks at time of LVAD surgery & again at time of heart transplant surgery

Population: Analysis not completed - study terminated due to funding pulled by sponsor

During the LVAD implant surgery, TEE and Transcranial Doppler will be conducted before and after the LVAD implant/CoSeal™ administration to detect possible micro emboli in the left ventricle (TEE) and in the intra-cranial circulation (TCD). • Intra-operative evaluation of surgical adhesions during LVAD explantation/heart transplant.

Outcome measures

Outcome data not reported

Adverse Events

CoSeal Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BioGlue® Surgical Adhesive

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

Raquel R Bunge

Houston Methodist Research Institute

Phone: 713-441-3912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60