Spine Deformity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOrthoPAT
OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
DEVICEConstavac
Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Allogenic Blood Transfused Postoperatively | 48 hours postoperative | The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Levels, Post-Op Day 3 | 3 days postop | Hemoglobin levels will be measured post-operatively day 3 |
| Hemoglobin Levels, Post-Op Day 2 | 2 days postop | Hemoglobin levels will be measured post-operatively day 2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 33 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen Failure | 1 | 1 |
Baseline characteristics
| Characteristic | Constavac | OrthoPAT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 33 Participants | 68 Participants |
| Sex: Female, Male Female | 26 Participants | 28 Participants | 54 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 0 / 33 | 0 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
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.
Time frame: 48 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constavac | Volume of Allogenic Blood Transfused Postoperatively | 458.33 mL | Standard Deviation 4.28 |
| OrthoPAT | Volume of Allogenic Blood Transfused Postoperatively | 382.35 mL | Standard Deviation 62.22 |
Secondary
Hemoglobin Levels, Post-Op Day 2
Hemoglobin levels will be measured post-operatively day 2
Time frame: 2 days postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constavac | Hemoglobin Levels, Post-Op Day 2 | 9.33 g/Dl (grams/deciliter) | Standard Deviation 0.88 |
| OrthoPAT | Hemoglobin Levels, Post-Op Day 2 | 10.19 g/Dl (grams/deciliter) | Standard Deviation 1.24 |
Secondary
Hemoglobin Levels, Post-Op Day 3
Hemoglobin levels will be measured post-operatively day 3
Time frame: 3 days postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constavac | Hemoglobin Levels, Post-Op Day 3 | 9.07 g/Dl (grams/deciliter) | Standard Deviation 0.79 |
| OrthoPAT | Hemoglobin Levels, Post-Op Day 3 | 9.9 g/Dl (grams/deciliter) | Standard Deviation 0.99 |