Coronary Artery Bypass Grafting
Conditions
Brief summary
A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone marrow in patients undergoing cardiothoracic surgery.
Detailed description
A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) composed of synthetic materials and hydroxyapatite on the reduction of bleeding from the sternal bone marrow in patients undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair. This product will be compared to the similar, currently used product, Ostene®. Bleeding will be evaluated qualitatively by the surgeon as well as quantitatively by comparing pre- and post-operative hemoglobin levels, intra-operative and post-operative blood product usage, and post-operative chest tube output. A 30 day follow-up will be conducted to evaluate the patient's tolerance of the product, possible complications, or infection. Additionally, surgeons will be asked to comment on the ease of use of the product.
Interventions
DEVICEBoneSeal
BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.
DEVICEOstene
OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consent given by patient prior to surgery 2. Adult patients over 45 years 3. Subjects requiring elective, prescheduled or urgent open heart surgery requiring a sternotomy including, but not limited to CABG, valve repair, valve replacement
Exclusion criteria
1. An immune system disorder 2. Known hypersensitivity to components in BoneSeal® or Ostene® 3. Patients undergoing emergency surgery 4. Patients undergoing aortic dissection 5. No consent given
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use | The time frame for assessing the ease of product application is the short interval a the conclusion of the operation when we are applying the topical hemostatic agent to the sternal bone marrow. In other words at the end of the case, this takes <10 min. | Qualitative determination of product application and hemostatic qualities graded by the surgeon using a scale from 1-5 with 1 being very easy and 5 being very difficult |
| Number of Participants Experiencing Re-bleed | 0-3 hours | Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur. |
| Hemoglobin | Pre-operative (baseline) and Post-operative (3-6 hours after baseline) | Postoperative hemoglobin as compared to baseline preoperative readings |
| Intra-operative Blood Units | 0-3 hours | Units of blood/blood products transfused during surgery |
| Surgical Site Drainage | 6, 12, 18 and 24 hours | Post-operative chest tube output |
| Number of Participants With Post Operative Complications Related to the Device | 30 days | Sternal wound infection or other complications related to the device or its use within 30 days post procedure |
| Number of Participants Requiring Use of Another Product During Surgery | During surgery, up to 3 hours | The surgeon's determination and need for the use of another product (FloSeal) during surgery to stop bleeding or re-bleed at the sternum. |
| End of Surgery Bleeding | End of surgery (closure of the chest) | Qualitative determination of of the amount of bleeding at the sternum at the end of surgery by the surgeon using a scale from 1-5 with 1 none and 5 being perfuse |
| Post-operative Blood Units | 3-24 hours | Units of blood/blood products transfused within 24 hours post surgery |
| Number of Participants With Infection | 30 days | The presence of an infection at the sternum at any time up to 30 days post surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ostene Ostene: OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically. | 30 |
| BoneSeal BoneSeal: BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348. | 27 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 3 |
Baseline characteristics
| Characteristic | BoneSeal | Total | Ostene |
|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 8 | 64.8 years STANDARD_DEVIATION 8.9 | 68.9 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 22 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 35 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 17 Participants | 39 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 27 |
| other Total, other adverse events | 1 / 30 | 0 / 27 |
| serious Total, serious adverse events | 1 / 30 | 0 / 27 |
Outcome results
Primary
Ease of Use
Qualitative determination of product application and hemostatic qualities graded by the surgeon using a scale from 1-5 with 1 being very easy and 5 being very difficult
Time frame: The time frame for assessing the ease of product application is the short interval a the conclusion of the operation when we are applying the topical hemostatic agent to the sternal bone marrow. In other words at the end of the case, this takes <10 min.
Population: Subjects undergoing Coronary Artery Bypass Grafting with or without valve replacement repair requiring hemostatic product for cut sternal bone site.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ostene | Ease of Use | 4 units on a scale |
| BoneSeal | Ease of Use | 1 units on a scale |
Primary
End of Surgery Bleeding
Qualitative determination of of the amount of bleeding at the sternum at the end of surgery by the surgeon using a scale from 1-5 with 1 none and 5 being perfuse
Time frame: End of surgery (closure of the chest)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ostene | End of Surgery Bleeding | 4 units on a scale |
| BoneSeal | End of Surgery Bleeding | 2 units on a scale |
Primary
Hemoglobin
Postoperative hemoglobin as compared to baseline preoperative readings
Time frame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Population: Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and needing hemostatic products be used on cut sternal bone site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ostene | Hemoglobin | Pre-operative Hemoglobin | 12.7 g/dL | Standard Deviation 2.1 |
| Ostene | Hemoglobin | Post-operative hemoglobin | 9.9 g/dL | Standard Deviation 2 |
| BoneSeal | Hemoglobin | Pre-operative Hemoglobin | 12.7 g/dL | Standard Deviation 2.1 |
| BoneSeal | Hemoglobin | Post-operative hemoglobin | 10.9 g/dL | Standard Deviation 2.1 |
Primary
Intra-operative Blood Units
Units of blood/blood products transfused during surgery
Time frame: 0-3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ostene | Intra-operative Blood Units | 0.50 Blood Units | Standard Deviation 0.96 |
| BoneSeal | Intra-operative Blood Units | 0.26 Blood Units | Standard Deviation 0.81 |
Primary
Number of Participants Experiencing Re-bleed
Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.
Time frame: 0-3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ostene | Number of Participants Experiencing Re-bleed | 25 Participants |
| BoneSeal | Number of Participants Experiencing Re-bleed | 3 Participants |
Primary
Number of Participants Requiring Use of Another Product During Surgery
The surgeon's determination and need for the use of another product (FloSeal) during surgery to stop bleeding or re-bleed at the sternum.
Time frame: During surgery, up to 3 hours
Population: Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and in need of a hemostatic agent be applied on cut sternal bone site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ostene | Number of Participants Requiring Use of Another Product During Surgery | 13 Participants |
| BoneSeal | Number of Participants Requiring Use of Another Product During Surgery | 1 Participants |
Primary
Number of Participants With Infection
The presence of an infection at the sternum at any time up to 30 days post surgery.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ostene | Number of Participants With Infection | 1 Participants |
| BoneSeal | Number of Participants With Infection | 0 Participants |
Primary
Number of Participants With Post Operative Complications Related to the Device
Sternal wound infection or other complications related to the device or its use within 30 days post procedure
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ostene | Number of Participants With Post Operative Complications Related to the Device | 2 Participants |
| BoneSeal | Number of Participants With Post Operative Complications Related to the Device | 0 Participants |
Primary
Post-operative Blood Units
Units of blood/blood products transfused within 24 hours post surgery
Time frame: 3-24 hours
Population: Subjects undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair and needing hemostatic products be used on cut sternal bone site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ostene | Post-operative Blood Units | 0.50 Blood Units | Standard Deviation 0.96 |
| BoneSeal | Post-operative Blood Units | 0.26 Blood Units | Standard Deviation 0.81 |
Primary
Surgical Site Drainage
Post-operative chest tube output
Time frame: 6, 12, 18 and 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ostene | Surgical Site Drainage | 6 Hour | 309.3 mL | Standard Deviation 245.1 |
| Ostene | Surgical Site Drainage | 12 Hour | 463.7 mL | Standard Deviation 338.7 |
| Ostene | Surgical Site Drainage | 18 Hour | 598.4 mL | Standard Deviation 380.6 |
| Ostene | Surgical Site Drainage | 24 Hour | 683.5 mL | Standard Deviation 409.5 |
| BoneSeal | Surgical Site Drainage | 24 Hour | 647.1 mL | Standard Deviation 409.5 |
| BoneSeal | Surgical Site Drainage | 6 Hour | 294.3 mL | Standard Deviation 245.1 |
| BoneSeal | Surgical Site Drainage | 18 Hour | 568.3 mL | Standard Deviation 380.6 |
| BoneSeal | Surgical Site Drainage | 12 Hour | 439.3 mL | Standard Deviation 338.7 |