Hemorrhage, Surgical
Conditions
Keywords
Hemostatic patch, Surgical sealant, Open Liver Surgery, Hemostasis
Brief summary
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
Detailed description
The GATT-Patch study is a prospective, single arm, multicenter, pre-market, first-in-man clinical investigation, that intents to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery. The clinical investigation will be carried out in a maximum of 7 sites in The Netherlands, treating an estimated total of 51 participants. All participants will be thoroughly screened and if found eligible, treated with GATT-Patch during open liver surgery. Participants will be followed for 6 weeks with an additional ultrasound assessment at the 6 week follow up visit. The participant enrolment period is expected to take approximately 6 months, with a total expected duration of the clinical investigation of approximately 8 months.
Interventions
DEVICEGATT-Patch
Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery
Sponsors
Avania
GATT Technologies BV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participant is scheduled to undergo an elective open surgery on the liver; * Participant is willing and able to give written informed consent for investigation participation; * Participant is 18 years of age or older at the time of enrollment; * Participant has been informed of the nature of the clinical investigation. A participant must meet all of the following intraoperative inclusion criteria to be treated with the investigational device: * Participant in whom the Investigator is able to identify a target bleeding site at the liver resection plane for which any applicable conventional means for hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical and the choice is made to use a topical hemostat for control of hemostasis; and the choice is made to use a topical hemostat for control of hemostasis; * Participant has a minimal, mild, or moderate target bleeding;
Exclusion criteria
* Participant is scheduled to undergo surgery on other organs besides the liver (e.g. pancreas, colon, lungs); * Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, allowing exclusive use of acetylsalicylic acid; * Participant has platelet count \<100 x 10ˆ9/L, an activates partial thrombin time of \>100s, or international normalized ratio \>2.5; * Participant is pregnant, planning on becoming pregnant or actively breast-feeding during the follow-up period; * Participant has a known hypersensitivity to brilliant blue (FD&C Blue #1); * Participant has an active or suspected infection at the surgical site; * Participant has a total bilirubin level of ≥ 2.5 mg/dl * Participant has had or has planned to receive any organ transplantation; * Participant has American Association of Anesthesiologists (ASA) classification of 4/5; * Participant has a life expectancy of less than 3 months; * Participant has a documented severe congenital or acquired immunodeficiency; * Participant in whom the investigational device will be used at the site of a synthetic graft or patch implant; * Participant is currently participating or has participated in another clinical investigation within the past 30 days that may affect the endpoints of the study, such as trials related to the surgical procedure, and on anti-coagulation; * Participant is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator; * Participant has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis | During procedure | Performance of GATT-Patch in achieving hemostasis at 3 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Hemostasis (Seconds) | During procedure | The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals. |
| Hemostasis at Different Timepoints | During procedure | The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined. |
Countries
Netherlands
Participant flow
Recruitment details
A total of 56 patients provided informed consent. There were 47 patients that received GATT-Patch during surgery.
Participants by arm
| Arm | Count |
|---|---|
| GATT-Patch GATT-Patch will be used to control bleeding during open liver surgery. Each surgery will be performed according to the standard procedures at the hospital, with the exception of the use of GATT-Patch.
GATT-Patch: Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | GATT-Patch |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 13.2 |
| Hemoglobin, g/dL | 8.3 g/dL STANDARD_DEVIATION 0.8 |
| Hereditary blood disorders, % | 1 Participants |
| Indication for surgery Cholangiocarcinoma | 4 Participants |
| Indication for surgery Colorectal carcinoma metastases | 31 Participants |
| Indication for surgery Hepatocellular carcinoma | 5 Participants |
| Indication for surgery Non-colorectal carcinoma metastases | 4 Participants |
| Indication for surgery Other | 3 Participants |
| Platelet count, 10^9/L | 219.4 10^9 platelets/L STANDARD_DEVIATION 79.1 |
| Previous abdominal surgery, % | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 33 Participants |
| Total bilirubin, umol/L | 9.3 umol/L STANDARD_DEVIATION 4.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 14 / 47 |
| serious Total, serious adverse events | 7 / 47 |
Outcome results
Primary
Hemostasis
Performance of GATT-Patch in achieving hemostasis at 3 minutes
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GATT-Patch Stage II Patients | Hemostasis | 38 Participants |
| GATT-Patch All Patients | Hemostasis | 46 Participants |
Secondary
Hemostasis at Different Timepoints
The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined.
Time frame: During procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GATT-Patch Stage II Patients | Hemostasis at Different Timepoints | Hemostasis at 30 seconds | 32 participants |
| GATT-Patch Stage II Patients | Hemostasis at Different Timepoints | Hemostasis at 1 minute | 37 participants |
| GATT-Patch Stage II Patients | Hemostasis at Different Timepoints | Hemostasis at 90 seconds | 37 participants |
| GATT-Patch Stage II Patients | Hemostasis at Different Timepoints | Hemostasis at 120 seconds | 37 participants |
| GATT-Patch Stage II Patients | Hemostasis at Different Timepoints | Hemostasis at 150 seconds | 37 participants |
| GATT-Patch Stage II Patients | Hemostasis at Different Timepoints | Hemostasis at 3 minutes | 38 participants |
Secondary
Mean Time to Hemostasis (Seconds)
The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals.
Time frame: During procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GATT-Patch Stage II Patients | Mean Time to Hemostasis (Seconds) | 54.6 seconds | Standard Deviation 107.5 |