Fibrin Sealant Vascular Surgery Study | NCT00576420

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FS VH S/D 500 s-apr - 60-Seconds	Experimental	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time	Biological: FS VH S/D 500 s-apr, 60-seconds polymerization time
FS VH S/D 500 s-apr - 120-Seconds	Experimental	FS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time	Biological: FS VH S/D 500 s-apr, 120-seconds polymerization time
Control Group- Manual compression with surgical gauze pads	Active Comparator	Treatment of the study-suture line will be manual compression with surgical gauze pads.	Procedure: Manual compression with surgical gauze pads

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FS VH S/D 500 s-apr, 60-seconds polymerization time	Biological	FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.	Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: Did not achieve hemostasis at 4 minutes Required additional hemostatic treatment during the first 4 minutes of the observation period Experienced rebleeding after the first 4 minutes of the observation period.	4 minutes post start of treatment application
90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line	Hemostasis at the study suture line must be maintained until closure of the surgical wound. Participants were considered treatment failures if they met any of the following conditions: Did not achieve hemostasis at 4 minutes Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period Experienced rebleeding after the first 4 minutes of the observation period.	4 minutes post start of treatment application
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding	Investigators were shown videos of bleeding severities to standardize assessments. Moderate bleeding defined as: Either >25% of the suture line bleeds, or ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or 1 pulsatile suture line bleeding was present. Severe bleeding defined as: Either >50% of the suture line bleeds, or ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or >1 pulsatile suture line bleeding was present, or ≥1 spurting suture line bleeding was present.	4 minutes post start of treatment application
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Hemostasis at 6 Minutes	Hemostasis at the study suture line must be maintained until closure of the surgical wound.	6 minutes post start of treatment application start
Percentage of Participants Achieving Hemostasis at 10 Minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female of all ages
Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses [including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass], or arteriovenous dialysis access shunt in the upper or lower extremity.
Signed informed consent

Intraoperative inclusion criterion:

- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).

Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)

Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.

Exclusion Criteria:

Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
Pregnant or lactating women
Congenital coagulation disorders
Prior kidney transplantation
Heparin-induced thrombocytopenia
Known prior exposure to aprotinin within the last 12 months
Known hypersensitivity to aprotinin or other components of the product
Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
Prior radiation therapy to the operating field
Severe local inflammation at the operating field.

Intraoperative exclusion criterion:

Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (e.g. abandonment of ePTFE graft placement).

PubMed Identifier	Type	Citation	Retractions
21514114	Result	Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FS VH S/D 500 S-apr - 60 Seconds	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
FG001	FS VH S/D 500 S-apr - 120 Seconds

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.

Hemostasis at the study suture line must be maintained.

Participants were considered treatment failures if they met any of the following conditions:

Did not achieve hemostasis at 4 minutes
Required additional hemostatic treatment during the first 4 minutes of the observation period
Experienced rebleeding after the first 4 minutes of the observation period.

Intent to Treat

Posted

Number

percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr- 60-Seconds	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts
Participants	OG00026 OG00124 OG00223

Title

Denominators

Categories

Primary Hemostasis Achieved at 4 Minutes

Title	Measurements
	OG00046.2 OG00162.5 OG00234.8

Additional Treatment Required for Hemostasis

Primary

90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Participants were considered treatment failures if they met any of the following conditions:

Did not achieve hemostasis at 4 minutes
Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period
Experienced rebleeding after the first 4 minutes of the observation period.

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Primary

Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding

Investigators were shown videos of bleeding severities to standardize assessments.

Moderate bleeding defined as:
- Either >25% of the suture line bleeds, or
- ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or
- 1 pulsatile suture line bleeding was present.
Severe bleeding defined as:
- Either >50% of the suture line bleeds, or
- ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
- >1 pulsatile suture line bleeding was present, or
- ≥1 spurting suture line bleeding was present.

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Secondary

Percentage of Participants Achieving Hemostasis at 6 Minutes

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

6 minutes post start of treatment application start

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Hemostasis at 10 Minutes

Hemostasis at the study suture line must be maintained until closure of the surgical wound.

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

10 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line

Intraoperative rebleeding at the study suture line after occurrence of hemostasis.

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

Intraoperative day 0

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line

Any rebleeding requiring surgical reexploration

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

Postoperative through day 30 ± 5

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization.
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts
Participants

Secondary

Percentage of Participants With Any Transfusion Requirement

Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

Intraoperative (day 0) through day 30 ± 5

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Graft Occlusions

Determined clinically and defined as absence of blood flow through the graft.

Safety Analysis Set

Posted

Number

90% Confidence Interval

percentage of participants

Day 0 (procedure day) through day 30 ± 5

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-Seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	FS VH S/D 500 S-apr - All - (60 + 120 Seconds)	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group	Manual compression with surgical gauze pads

Secondary

Percentage of Participants With Infections at the Surgical Site

Safety Analysis Set

Posted

Number

90% Confidence Interval

percentage of participants

Day 0 (procedure day) through day 30 ± 5

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	FS VH S/D 500 S-apr All - (60 + 120 Seconds)	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group	Manual compression with surgical gauze pads

Secondary

Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline

Safety Analysis Set

Posted

Median

Full Range

mm Hg

Within 14 days prior to date of surgery

ID	Title	Description
OG000	FS VH S/D 500 S -Apr - 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)
OG001	FS VH S/D 500 S -Apr - 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)
OG002	FS VH S/D 500 S-apr - All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads

Secondary

Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure

Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Safety Analysis Set

Posted

Median

Full Range

percent change

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline - Intraoperative Day 0	FS VH S/D 500 s-apr (FS), 60-seconds polymerization
OG001	FS 120: Preoperative Baseline - Intraoperative Day 0	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline - Intraoperative Day 0	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline - Intraoperative Day 0

Secondary

Vital Signs: Heart Rate - Preoperative Baseline

Safety Analysis Set

Posted

Median

Full Range

Heart beats/ minute

Within 14 days prior to date of surgery

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads

Secondary

Percent Change in Vital Signs: Heart Rate

Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Safety Analysis Set

Posted

Median

Full Range

percent change

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline - Intraoperative Day 0	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline - Intraoperative Day 0	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline - Intraoperative Day 0	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline - Intraoperative Day 0

Secondary

Vital Signs: Respiratory Rate - Preoperative Baseline

Safety Analysis Set

Posted

Median

Full Range

Breaths/ minute

Within 14 days prior to date of surgery

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads

Secondary

Percent Change in Vital Signs: Respiratory Rate

Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14

Safety Analysis Set

Posted

Median

Full Range

percent change

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline - Postoperative Day 1	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline - Postoperative Day 1	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline - Postoperative Day 1	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline - Postoperative Day 1

Secondary

Laboratory Values Over Time: Hemoglobin

Safety Analysis Set

Posted

Median

Full Range

g/dl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Hematocrit

Safety Analysis Set

Posted

Median

Full Range

percentage of red blood cells in blood

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Erythrocytes

Safety Analysis Set

Posted

Median

Full Range

x10^6/µl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes

Safety Analysis Set

Posted

Median

Full Range

x10^3/µl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Platelets

Safety Analysis Set

Posted

Median

Full Range

x10^3/µl

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)

Safety Analysis Set

Posted

Median

Full Range

mg/dL

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Alanine Aminotransferase (ALT)

Safety Analysis Set

Posted

Median

Full Range

U/L

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Aspartate Aminotransferase (AST)

Safety Analysis Set

Posted

Median

Full Range

U/L

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)

Safety Analysis Set

Posted

Median

Full Range

seconds

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Secondary

Laboratory Values Over Time: International Normalized Ratio (INR)

Safety Analysis Set

Posted

Median

Full Range

ratio

Preoperative baseline through postoperative Day 14

ID	Title	Description
OG000	FS 60: Preoperative Baseline	FS VH S/D 500 s-apr, 60-seconds polymerization
OG001	FS 120: Preoperative Baseline	FS VH S/D 500 s-apr, 120-seconds polymerization
OG002	FS All: Preoperative Baseline	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time FS VH S/D 500 s-apr, 120-seconds polymerization time
OG003	Control Group: Preoperative Baseline	Manual compression with surgical gauze pads
OG004	FS 60: Postoperative Day 14

Primary

Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding

Investigators were shown videos of bleeding severities to standardize assessments.

Severe bleeding defined as:

Either >50% of the suture line bleeds, or
≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or
>1 pulsatile suture line bleeding was present, or
≥1 spurting suture line bleeding was present.

Intent to Treat

Posted

Number

90% Confidence Interval

percentage of participants

4 minutes post start of treatment application

ID	Title	Description
OG000	FS VH S/D 500 S-apr - 60-Seconds	FS VH S/D 500 s-apr, 60-seconds polymerization time
OG001	FS VH S/D 500 S-apr - 120-Seconds	FS VH S/D 500 s-apr, 120-seconds polymerization time
OG002	Control Group	Manual compression with surgical gauze pads.

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fibrin Sealant - 60 Seconds	Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time	4	26	4	26
EG001	Fibrin Sealant - 120 Seconds	FS VH S/D 500 s-apr, 120 seconds polymerization time	4	24	9	24
EG002	Fibrin Sealant All - (60 + 120 Seconds)	All study participants who received Fibrin Sealant (60 + 120 Seconds): Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time FS VH S/D 500 s-apr, 120 seconds polymerization time	8	50	13	50
EG003	Control Group	Treatment of the study-suture line will be manual compression with surgical gauze pads.	4	23	7	23

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected26 at risk EG0010 events0 affected24 at risk EG0021 events1 affected50 at risk EG0030 events0 affected23 at risk
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0001 events1 affected26 at risk EG0011 events1 affected24 at risk EG0022 events2 affected50 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	EG0001 events1 affected26 at risk EG0010 events0 affected24 at risk EG0021 events1 affected50 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (Unspecified)	EG0001 events1 affected26 at risk EG0010 events0 affected24 at risk EG0021 events1 affected50 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0011 events1 affected24 at risk EG0021 events1 affected50 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0011 events1 affected24 at risk EG0021 events1 affected50 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0011 events1 affected24 at risk EG0021 events1 affected50 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Incision site complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0003 events2 affected26 at risk EG0012 events2 affected24 at risk EG0025 events4 affected50 at risk EG0030 events0 affected23 at risk
Incision site oedema	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0002 events2 affected26 at risk EG0011 events1 affected24 at risk EG0023 events3 affected50 at risk EG003
Incision site erythema	Injury, poisoning and procedural complications	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0012 events2 affected24 at risk EG0022 events2 affected50 at risk EG003
Oedema peripheral	General disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0012 events2 affected24 at risk EG0022 events2 affected50 at risk EG003
Ventricular tachycardia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0012 events2 affected24 at risk EG0022 events2 affected50 at risk EG003
Pyrexia	General disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0012 events2 affected24 at risk EG0022 events2 affected50 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	EG0000 events0 affected26 at risk EG0010 events0 affected24 at risk EG0020 events0 affected50 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Title	Description
BG000	FS VH S/D 500 S-apr - 60 Seconds	FS VH S/D 500 s-apr, 60 - seconds polymerization time
BG001	FS VH S/D 500 S-apr - 120 Seconds	FS VH S/D 500 s-apr, 120 - seconds polymerization time
BG002	Control Group	Manual compression with surgical gauze pads.
BG003	Total	Total of all reporting groups

ID	Term
D026502	LDL-Receptor Related Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011973	Receptors, LDL
D018110	Receptors, Lipoprotein
D011956	Receptors, Cell Surface
D008565	Membrane Proteins