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The aim of the study is to determine if the use of iv TXA or Aquamantys system improve the postoperative hemoglobin and hematocrit after primary TKA and what is the effect of the simultaneous use of iv TXA and Aquamantys on the postoperative hemoglobin and hematocrit. The assumption is that the combination of iv TXA and Aquamantys system will enable an improvement in the postoperative hemoglobin and hematocrit equal or larger than the improvement generated by the use of Aquamantys system alone.
The study is randomized, placebo controlled. The study population includes patients older than 18 years of age undergoing elective total primary knee replacement under spinal anesthesia. All patients enrolled in the study will undergo TKA performed by the same orthopedic surgeon. Since controversies exist regarding the effect of different types of anesthesia (general anesthesia versus spinal or epidural anesthesia) on intraoperative blood loss, in order to eliminate an important confounding variable we decided to exclusively enroll for our study patients that qualify for and agree with spinal anesthesia to be used as the main anesthetic technique for their TKA.
All clinical trial procedures will be performed by personnel blinded to study treatment assignment. Unblinding is only allowed for safety concerns in an emergency situation.The only other exception is represented by the surgeon, who can't be blinded in regards to using Aquamantys system and the bipolar sealer. Once a subject becomes eligible for the trial, the investigator or the designee will access the randomization system.
Enrolled subjects will be assigned to one of the 4 groups by block randomization of alternating 4 and 8 and 12 patients per block. The Pharmacy Department will provide the iv placebo or the iv TXA according to the randomization process.
This clinical trial will be conducted in accordance to this protocol, Good Clinical Practice and applicable regulatory requirements
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Active Comparator | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes |
|
| Aquamantys System | Active Comparator | The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts |
|
| TXA plus Aquamantys | Active Comparator | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes. The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts. |
|
| Control | Placebo Comparator | Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | see arm/group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Hemoglobin (Hb) From the Day of Surgery |
| day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
| The Change in Hematocrit (Ht) From the Day of Surgery |
| day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Blood Loss | The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross's formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below: Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial - Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Sorondo, MD | Eastern Maine Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes Tranexamic Acid: see arm/group descriptions |
| FG001 | Aquamantys System | The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts Aquamantys System: see arm/group descriptions |
| FG002 | TXA Plus Aquamantys | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes. The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts. Tranexamic Acid: see arm/group descriptions Aquamantys System: see arm/group descriptions |
| FG003 | Control | Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes Control Group: Saline and Standard Elecdrocautery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes Tranexamic Acid: see arm/group descriptions |
| BG001 | Aquamantys System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change in Hemoglobin (Hb) From the Day of Surgery |
| Posted | Mean | Standard Deviation | g/dl | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes Tranexamic Acid: see arm/group descriptions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandru Seviciu | Eastern Maine Medical Center | 207-973-5918 | aseviciu@emhs.org |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Aquamantys System | Device | see arm/group descriptions |
|
| Control | Other | Standard Electro-cautery and Saline |
|
|
| day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
| Cost Analysis | Charges per case. | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
| Adverse Events | Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA) | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts Aquamantys System: see arm/group descriptions |
| BG002 | TXA Plus Aquamantys | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes. The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts. Tranexamic Acid: see arm/group descriptions Aquamantys System: see arm/group descriptions |
| BG003 | Control | Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes Control Group: Saline and Standard Elecdrocautery |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
| OG002 | TXA Plus Aquamantys | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes. The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts. Tranexamic Acid: see arm/group descriptions Aquamantys System: see arm/group descriptions |
| OG003 | Control | Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes Control Group: Saline and Standard Elecdrocautery |
|
|
| Primary | The Change in Hematocrit (Ht) From the Day of Surgery |
| Posted | Mean | Standard Deviation | Volume % of RBC in blood | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
|
|
|
| Secondary | Post Operative Blood Loss | The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross's formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below: Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial - Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two. | Posted | Mean | Standard Deviation | ml | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
|
|
|
| Secondary | Cost Analysis | Charges per case. | Posted | Mean | Standard Deviation | Dollars | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
|
|
|
| Secondary | Adverse Events | Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA) | Posted | Number | participants | day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Aquamantys System | The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts Aquamantys System: see arm/group descriptions | 0 | 32 | 0 | 32 |
| EG002 | TXA Plus Aquamantys | TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes. The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts. Tranexamic Acid: see arm/group descriptions Aquamantys System: see arm/group descriptions | 0 | 32 | 0 | 32 |
| EG003 | Control | Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes Control Group: Saline and Standard Elecdrocautery | 0 | 32 | 0 | 32 |
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