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The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.
The purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adult patients undergoing multilevel spine surgery for deformity. In addition, the ability of these drains to decrease the complications that are associated with allogenic blood exposure (postoperative infection, volume overload and transfusion reactions) will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OrthoPAT | Experimental | Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours. |
|
| Constavac | Active Comparator | Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OrthoPAT | Device | OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Allogenic Blood Transfused Postoperatively | The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place. | 48 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Levels, Post-Op Day 3 | Hemoglobin levels will be measured post-operatively day 3 | 3 days postop |
| Hemoglobin Levels, Post-Op Day 2 | Hemoglobin levels will be measured post-operatively day 2 |
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Inclusion Criteria:
The patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent
Exclusion Criteria:
The patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.
The patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Tom Ross, RN | Hospital for Special Surgery, New York | Study Director |
| Han Jo Kim, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Constavac | Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours. Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively |
| FG001 | OrthoPAT | Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours. OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Constavac | Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours. Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively |
| BG001 | OrthoPAT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Volume of Allogenic Blood Transfused Postoperatively | The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place. | Posted | Mean | Standard Deviation | mL | 48 hours postoperative |
|
From time of surgery to post-op day 3.
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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 | OrthoPAT | Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours. OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oheneba Boachie-Adjei, MD | Hospital for Special Surgery | 212 606-1723 | rosst@hss.edu |
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| Constavac | Device | Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively |
|
| 2 days postop |
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours. OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Hemoglobin Levels, Post-Op Day 3 | Hemoglobin levels will be measured post-operatively day 3 | Posted | Mean | Standard Deviation | g/Dl (grams/deciliter) | 3 days postop |
|
|
|
| Secondary | Hemoglobin Levels, Post-Op Day 2 | Hemoglobin levels will be measured post-operatively day 2 | Posted | Mean | Standard Deviation | g/Dl (grams/deciliter) | 2 days postop |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Constavac | Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours. Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively | 0 | 35 | 0 | 35 | 0 | 35 |
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