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It is widely reported that a large percentage of total joint replacement patients receive allogeneic (human donor blood) blood transfusions due to perioperative blood loss with numbers ranging from 30% to 80%.
The risks of allogenic blood transfusion are well documented in the literature. In addition, they are time-consuming: often lengthening hospital stay and decreasing the availability for postoperative physical therapy. Moreover, they are costly at several hundred dollars per unit, and allogeneic transfusions are linked with immunosuppression and increased postoperative infection rates and wound healing problems, which are devastating complications in this elective, joint replacement population. Several options are available for diminishing the need for allogenic blood transfusion following elective total joint replacement. These include the use of perioperative blood salvage devices (OrthoPAT) and tranexamic acid. While there is data to support the use of both OrthoPat and Tranexamic acid in primary total joint arthroplasty, there is little information comparing one versus the other in terms of efficacy and economics.
The purpose of this study is to compare the safety, effectiveness and cost benefit of Hemovac drain, OrthoPAT and Tranexamic Acid to manage blood loss during total hip and total knee replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemovac drain | Active Comparator |
| |
| Re-infusion drain | Active Comparator |
| |
| Tranexamic drain | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemovac drain | Procedure | The Hemovac drain is a device placed under your skin used to collect blood during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Transfusion | Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups | Inpatient Postoperative, on average 3 days after surgery |
| Change in Hemoglobin Level | Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery. | Post-operative on day 2 (first day after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, PA | Charlotte | North Carolina | 28207 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemovac Drain | Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery. |
| FG001 | Re-infusion Drain | Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion. |
| FG002 | Tranexamic Drain | Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients who completed the study are included in the reported results. Patients that were withdrawn from the study did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemovac Drain | Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery. |
| BG001 | Re-infusion Drain | Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion. |
| 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 | Blood Transfusion | Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups | Posted | Number | participants | Inpatient Postoperative, on average 3 days after surgery |
|
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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 | Hemovac Drain | Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Occluded superficial femoral artery | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extended hospitalization | Surgical and medical procedures | Extended hospitalization stay, beyond the standard of care of 3 post-operative days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Research Scientist | OrthoCarolina Research Institute | 704-323-2265 | susan.odum@orthocarolina.com |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Re-infusion drain | Procedure | This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion. |
|
| Tranexamic drain | Procedure | Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. |
|
| BG002 | Tranexamic Drain | Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. |
|
|
| Primary | Change in Hemoglobin Level | Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery. | Posted | Median | Inter-Quartile Range | g/dl | Post-operative on day 2 (first day after surgery) |
|
|
|
| 1 |
| 61 |
| 2 |
| 61 |
| EG001 | Re-infusion Drain | Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion. | 0 | 60 | 0 | 60 |
| EG002 | Tranexamic Drain | Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding. | 1 | 65 | 1 | 65 |
| Reoperation | Surgical and medical procedures | Reoperation during index hospitalization stay |
|
|
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