Musculoskeletal Cancer, Sarcoma,Soft Tissue
Conditions
Brief summary
This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.
Detailed description
Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most often arthroplasty. The aim of this study is to determine in a randomized controlled fashion if there is any difference in perioperative blood loss and blood transfusion rates when TXA is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.
Interventions
DRUGTranexamic Acid (TXA)
Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants are randomized to one of four groups. One group is the bony tumor treated with TXA, second group is the bony tumor treated without TXA, third group is the soft tissue sarcoma treated with TXA, and the fourth group is soft tissue sarcoma treated without TXA.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing wide resection of a malignant bony tumor of the lower extremity with endoprosthetic reconstruction. * Patients undergoing a resection of soft tissue sarcoma measuring \> 5cm.
Exclusion criteria
* Patients undergoing revision endoprosthetic reconstruction * Patients with known coagulopathy * Known history of DVT or embolic disease * Benign tumors * Patients with allergy to TXA * Those refusing blood products * Those concurrently on anti-coagulant therapy * Pregnant and/or nursing women * Vulnerable populations as defined by the KUMC IRB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Blood Loss | During surgical procedure, 4 to 6 hours | How much blood was lost during surgical process |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bony Tumor Treated With Tranexamic Acid (TXA) This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.
Tranexamic Acid (TXA): Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure. | 0 |
| Bony Tumor Treated Without TXA This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction. | 3 |
| Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA) This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA
Tranexamic Acid (TXA): Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure. | 3 |
| Soft Tissue Sarcoma Treated Without TXA This group of participants will undergo soft tissue sarcoma resection of the lower extremity. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 3 | 3 | 6 |
Baseline characteristics
| Characteristic | Bony Tumor Treated With Tranexamic Acid (TXA) | Bony Tumor Treated Without TXA | Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA) | Soft Tissue Sarcoma Treated Without TXA | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 3 Participants | 6 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 3 | 0 / 3 | 0 / 6 |
| other Total, other adverse events | 0 / 0 | 0 / 3 | 0 / 3 | 0 / 6 |
| serious Total, serious adverse events | 0 / 0 | 0 / 3 | 0 / 3 | 0 / 6 |
Outcome results
Primary
Perioperative Blood Loss
How much blood was lost during surgical process
Time frame: During surgical procedure, 4 to 6 hours
Population: Bony tumor w/ TXA group had no participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bony Tumor no TXA Group | Perioperative Blood Loss | 283 mL |
| Soft Tissue Tumor w/ TXA Group | Perioperative Blood Loss | 700 mL |
| Soft Tissue Tumor With no TXA Group | Perioperative Blood Loss | 416 mL |