Phase 2
N=73
Fibrin Sealant Vascular Surgery Study
Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Bottom Line
View on ClinicalTrials.gov: NCT00576420 ↗Enrolled (actual)
73
Serious AEs
16.3%
Results posted
Nov 2012
Primary outcome: Primary: Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. — 46.2; 62.5; 34.8; 30.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FS VH S/D 500 s-apr, 60-seconds polymerization time (Biological); FS VH S/D 500 s-apr, 120-seconds polymerization time (Biological); Manual compression with surgical gauze pads (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. |
46.2; 62.5; 34.8; 30.8; 25.0; 52.2 | — |
| PRIMARY 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line |
46.2; 62.5; 34.8 | 0.1564 |
| PRIMARY Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding |
50.0; 66.7; 38.5 | — |
| PRIMARY Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding |
41.7; 58.3; 30.0 | — |
| SECONDARY Percentage of Participants Achieving Hemostasis at 6 Minutes |
61.5; 75.0; 34.8 | 0.060 |
| SECONDARY Percentage of Participants Achieving Hemostasis at 10 Minutes |
65.4; 75.0; 43.5 | 0.123 |
| SECONDARY Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line |
3.8; 0.0; 4.3 | 0.929 |
| SECONDARY Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line |
0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Any Transfusion Requirement |
3.8; 12.5; 13.0 | 0.234 |
| SECONDARY Percentage of Participants With Graft Occlusions |
7.7; 4.2; 6.0; 0.0 | 0.106 |
| SECONDARY Percentage of Participants With Infections at the Surgical Site |
3.8; 8.3; 6.0; 0.0 | 0.257 |
| SECONDARY Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline |
137.5; 142.5; 141.5; 150.0; 71.0; 73.5 | — |
| SECONDARY Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure |
-10.1; -6.5; -9.8; -17.2; -6.4; -12.4 | — |
| SECONDARY Vital Signs: Heart Rate - Preoperative Baseline |
72.0; 71.5; 72.0; 74.0 | — |
| SECONDARY Percent Change in Vital Signs: Heart Rate |
-7.0; -2.6; -6.3; -9.5; -6.7; 2.0 | — |
| SECONDARY Vital Signs: Respiratory Rate - Preoperative Baseline |
18.0; 20.0; 18.0; 18.0 | — |
| SECONDARY Percent Change in Vital Signs: Respiratory Rate |
0.0; -10.0; -10.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Laboratory Values Over Time: Hemoglobin |
12.00; 12.55; 12.25; 12.15; 11.15; 12.40 | — |
| SECONDARY Laboratory Values Over Time: Hematocrit |
37.00; 37.00; 37.00; 39.00; 35.00; 38.00 | — |
| SECONDARY Laboratory Values Over Time: Erythrocytes |
4.10; 4.15; 4.10; 4.40; 3.75; 4.15 | — |
| SECONDARY Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes |
6.31; 7.14; 6.62; 7.98; 6.58; 7.87 | — |
| SECONDARY Laboratory Values Over Time: Platelets |
184.00; 204.00; 195.50; 233.00; 226.00; 333.00 | — |
| SECONDARY Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN) |
4.20; 1.90; 3.50; 2.65; 4.60; 2.40 | — |
| SECONDARY Laboratory Values Over Time: Alanine Aminotransferase (ALT) |
16.00; 17.00; 16.00; 16.50; 12.00; 15.00 | — |
| SECONDARY Laboratory Values Over Time: Aspartate Aminotransferase (AST) |
18.00; 19.00; 18.00; 16.00; 18.00; 20.00 | — |
| SECONDARY Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT) |
25.10; 26.30; 25.90; 25.10; 24.65; 27.20 | — |
| SECONDARY Laboratory Values Over Time: International Normalized Ratio (INR) |
1.00; 1.10; 1.00; 1.05; 1.00; 1.00 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.
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).
Data sourced from ClinicalTrials.gov (NCT00576420). 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.