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FS VH S/D 500 s-apr, 60-seconds polymerization time · 4 trials · 6 indications
Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.
Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.
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.
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.
Investigators were shown videos of bleeding severities to standardize assessments. 1. 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. 2. 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.
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.
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | EXPERIMENTAL | FS VH S/D 500 s-apr (Tisseel), single use treatment, intraoperative |
| DuraSeal Dural Sealant | ACTIVE_COMPARATOR | DuraSeal Dural Sealant, single use treatment, intraoperative |
| FS VH S/D 4 s-apr | EXPERIMENTAL | One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| Standard of Care (SoC) | NO_INTERVENTION | Other side of face will receive standard of care. Please note: Each subject will participate in both arms (investigational product and standard of care) simultaneously, and will serve as his/her own control. |
| ARTISS | EXPERIMENTAL | ARTISS will be used as an adjuvant to standard of care. |
| Standard of care | OTHER | Standard of care |
| 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 |
| 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 |
| Control Group- Manual compression with surgical gauze pads | ACTIVE_COMPARATOR | Treatment of the study-suture line will be manual compression with surgical gauze pads. |
| Name | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | DRUG | - |
| DuraSeal Dural Sealant | DEVICE | - |
| FS VH S/D 4 s-apr | BIOLOGICAL | FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area. |
| FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) | BIOLOGICAL | Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed. |
| Standard of care | PROCEDURE | Standard of care |
| 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. |
| FS VH S/D 500 s-apr, 120-seconds polymerization time | BIOLOGICAL | Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps. |
| Manual compression with surgical gauze pads | PROCEDURE | Treatment of the study suture line with manual compression with surgical gauze pads. |
Inclusion Criteria: 1. Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region 2. Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed 3. Patients must be willing to receive per...
FS VH S/D 500 s-apr is a fibrin sealant developed as an adjunct to hemostasis in vascular surgery with synthetic vascular grafts. It has also been studied for cerebrospinal fluid leak, face-lift, and seroma. It is a two-component sealant made from pooled human plasma and is double virus inactivated.
FS VH S/D 500 s-apr is developed by Baxter International Inc., which trades under the ticker BAX. Baxter is the sponsor behind the clinical program evaluating this fibrin sealant across surgical and aesthetic indications.
FS VH S/D 500 s-apr is in Phase 2 development. It is an investigational product and is not approved. Its clinical program includes completed Phase 2 and Phase 3 studies, and no trials are currently active.
Completed studies include NCT02891070, a Phase 3 trial in cerebrospinal fluid leak with 224 patients, NCT00576420, a Phase 2 vascular surgery study with 101 patients, NCT00999141, a Phase 3 rhytidectomy trial with 75 patients, and NCT01112735, a Phase 2 abdominoplasty study with 40 patients.
FS VH S/D 500 s-apr is being studied as an adjunct to sutured dural repair in cranial surgery to address cerebrospinal fluid leak. The Phase 3 trial NCT02891070 evaluated its efficacy and safety in this indication across the United States, Czechia, Germany, and Spain.