Phase 3
N=140
FS VH S/D 500 S-apr in Vascular Surgery
Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
Bottom Line
View on ClinicalTrials.gov: NCT00892957 ↗Enrolled (actual)
140
Serious AEs
27.1%
Results posted
Nov 2012
Primary outcome: Primary: Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application. — 62.9; 31.4 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) (Biological); Surgical gauze pads (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application. |
62.9; 31.4 | <0.0001 sig |
| PRIMARY Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding |
75.9; 48.1 | — |
| PRIMARY Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding |
53.7; 20.9 | — |
| SECONDARY Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application |
71.4; 42.9 | 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application |
75.7; 55.7 | 0.012 sig |
| SECONDARY Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line |
5.7; 1.4 | 0.158 |
| SECONDARY Percentage of Participants With Postoperative Rebleeding |
0; 0 | — |
| SECONDARY Percentage of Participants With Graft Occlusion |
7.1; 11.4 | 0.380 |
| SECONDARY Percentage of Participants With Infection at the Surgical Site |
10.0; 7.1 | 0.545 |
| SECONDARY Number of Participants With Infections by Grade |
5; 3; 2; 1; 0; 1 | — |
| SECONDARY Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline |
139.5; 143.5; 73.0; 76.5 | — |
| SECONDARY Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure |
-15.63; -12.46; -8.33; -7.72; -2.59; -2.94 | — |
| SECONDARY Vital Signs: Heart Rate - Preoperative Baseline |
75.0; 75.0 | — |
| SECONDARY Percent Change in Vital Signs: Heart Rate |
-6.27; -2.12; 5.44; 4.84; 5.63; 0.00 | — |
| SECONDARY Vital Signs: Respiratory Rate - Preoperative Baseline |
18.0; 18.0 | — |
| SECONDARY Percent Change in Vital Signs: Respiratory Rate |
-10.00; -9.55; 0.00; -6.07 | — |
| SECONDARY Laboratory Values Over Time: Hemoglobin |
12.10; 11.60; 12.20; 11.80 | — |
| SECONDARY Laboratory Values Over Time: Hematocrit |
37.0; 36.0; 38.5; 37.0 | — |
| SECONDARY Laboratory Values Over Time: Erythrocytes |
4.20; 3.90; 4.10; 3.90 | — |
| SECONDARY Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes |
7.105; 8.260; 6.760; 7.980; 0.040; 0.040 | — |
| SECONDARY Laboratory Values Over Time: Platelets |
227.0; 303.0; 239.0; 283.0 | — |
| SECONDARY Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) |
1.80; 2.20; 2.90; 4.40; 0.30; 0.30 | — |
| SECONDARY Laboratory Values Over Time: Alanine Aminotransferase (ALT) |
16.0; 16.0; 14.0; 13.0 | — |
| SECONDARY Laboratory Values Over Time: Aspartate Aminotransferase (AST) |
21.0; 20.5; 19.0; 20.0 | — |
| SECONDARY Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) |
24.40; 25.10; 25.20; 25.80 | — |
| SECONDARY Laboratory Values Over Time: International Normalized Ratio(INR) |
1.00; 1.00; 1.00; 1.00 | — |
Summary
The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.
Eligibility Criteria
Inclusion Criteria
Preoperative inclusion criteria:
- Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:
- axillo-femoral
- axillo-bifemoral
- aorto-bifemoral
- ilio-femoral
- femoro-femoral
- ilio-popliteal
- femoro-popliteal (including below knee)
- femoro-tibial vessel bypass
- arterio-venous shunting for dialysis access in the upper or lower extremity
- Signed informed consent
- Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
- Subject is willing and able to comply with the requirements of the protocol.
Intraoperative inclusion criterion:
- Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)
Exclusion Criteria
Preoperative exclusion criteria:
- Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
- Congenital coagulation disorders
- Prior kidney transplantation
- Heparin-induced thrombocytopenia
- Known hypersensitivity to heparin
- Known hypersensitivity to aprotinin or other components of the product
- Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)
- Prior radiation therapy to the operating field
- Severe local inflammation at the operating field
- Subject is pregnant or lactating at the time of enrollment
- Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.
Intraoperative Exclusion Criteria:
- 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, (eg, abandonment of ePTFE graft placement)
Data sourced from ClinicalTrials.gov (NCT00892957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.