A Phase 4 interventional study of Hemostatic Matrix in Blood Loss, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.
Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.
As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 196 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 vials of Floseal applied once at the end of surgery
Drug: Hemostatic Matrix
No intervention.
FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Also known as: "FloSeal", a thrombin and collagen based agent
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and on the day of surgery
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Time frame: preoperatively and 1 day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Drain Output
Time frame: 24 hours postoperatively
Autologous Amount of Transfusion
Time frame: three days postoperatively
Homologous Amount of Transfusion
Time frame: three days postoperatively
Range of Motion on Day 3
Time frame: 3days postoperatively
Visual Analog Pain Scale on Day 3
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Time frame: 3 days postoperatively
Range of Motion at Six Weeks
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale at 6 Weeks
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
Time frame: 6 weeks postoperatively
Inclusion Criteria: 1)Diagnosis of knee arthritis in patients medically suitable to undergo unilateral TKA. Pre-operative Exclusion Criteria: 1. Known allergies to products of bovine origin. 2. History of bleeding disorders. 3. Pre- or peri-operative complication.
| Milestone | Hemostatic Matrix | Control |
|---|---|---|
| Started | 97 | 99 |
| Completed | 97 | 99 |
| Not completed | 0 | 0 |
| g/dL | Hemostatic Matrix | Control |
|---|---|---|
| Change in Hemoglobin on Day 0 Compared to Preoperatively | -1.277 ± .880 | -1.241 ± .883 |
| g/L | Hemostatic Matrix | Control |
|---|---|---|
| Change in Hemoglobin on Day 0 Compared to Preoperatively | -4.484 ± 2.637 | -4.305 ± 2.682 |
| g/dL | Hemostatic Matrix | Control |
|---|---|---|
| Change in Hemoglobin On Day 1 Compared to Preoperatively | -1.528 ± 1.132 | -1.816 ± 1.168 |
| degrees | Hemostatic Matrix | Control |
|---|---|---|
| Range of Motion on Day 3 | 67.88 ± 14.54 | 68.96 ± 16.01 |
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
| points on visual analog pain scale | Hemostatic Matrix | Control |
|---|---|---|
| Visual Analog Pain Scale on Day 3 | 2.99 ± 2.311 | 2.78 ± 2.44 |
| g/L | Hemostatic Matrix | Control |
|---|---|---|
| Change in Hematocrit on Day 1 Compared to Preoperatively | -5.075 ± 3.298 | -5.749 ± 3.652 |
| degrees | Hemostatic Matrix | Control |
|---|---|---|
| Range of Motion at Six Weeks | 111.41 ± 14.25 | 112.97 ± 12.92 |
| g/dL | Hemostatic Matrix | Control |
|---|---|---|
| Change in Hemoglobin on Day 2 Compared to Preoperatively | -2.265 ± 1.443 | -2.359 ± 1.246 |
| g/L | Hemostatic Matrix | Control |
|---|---|---|
| Change in Hematocrit on Day 2 Compared to Preoperatively | -7.013 ± 4.183 | -7.418 ± 3.904 |
| mL | Hemostatic Matrix | Control |
|---|---|---|
| Drain Output | 711 ± 287 | 702 ± 314.7 |
| units of blood | Hemostatic Matrix | Control |
|---|---|---|
| Autologous Amount of Transfusion | .828 ± .746 | .854 ± .754 |
| units of blood | Hemostatic Matrix | Control |
|---|---|---|
| Homologous Amount of Transfusion | .247 ± .525 | .337 ± .738 |
A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.
| points on visual analog pain scale | Hemostatic Matrix | Control |
|---|---|---|
| Visual Analog Pain Scale at 6 Weeks | 2.753 ± 2.09 | 2.91 ± 2.17 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hemostatic Matrix | — | 0/97 (0%) | 5/97 (5.2%) |
| Control | — | 0/99 (0%) | 6/99 (6.1%) |
| Event | Hemostatic Matrix | Control |
|---|---|---|
| Manipulation Under Anesthesia Needed to Achieve Improved Range of MotionSurgical and medical procedures | 2/97 | 2/99 |
| CellulitisSkin and subcutaneous tissue disorders | 1/97 | 1/99 |
| Deep Venous ThrombosesVascular disorders | 1/97 | 1/99 |
| Suture Abscess with CellulitisSkin and subcutaneous tissue disorders | 1/97 | 1/99 |
| Paralytic IleusGastrointestinal disorders | 0/97 | 1/99 |
| Age, Categorical(Participants) | Hemostatic Matrix | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 73 | 93 |
| >=65 years | 77 | 26 | 103 |
| Age, Continuous(years) | Hemostatic Matrix | Control | Total |
|---|---|---|---|
| Mean | 72.78 ± 8.90 | 70.40 ± 10.47 | 71.58 ± 9.77 |
| Sex: Female, Male(Participants) | Hemostatic Matrix | Control | Total |
|---|---|---|---|
| Female | 65 | 71 | 136 |
| Male | 32 | 28 | 60 |
| Region of Enrollment(participants) | Hemostatic Matrix | Control | Total |
|---|---|---|---|
| United States | 97 | 99 | 196 |
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Hospital for Special Surgery, New York