MDACC Study Summary 2004-0743

Study Summary
No. 2004-0743:.......Other Studies......Patrick Lin......Orthopaedic Oncology

Study Summary Title



Study Summary Number:	2004-0743

Study Title:	DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

Physician

New Patient Referral



Name:	Patrick Lin	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Orthopaedic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4117 Contact us about clinical trials

General Information



Disease Group:	Other Studies	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Return visits will be as standard of post-operative care.

Treatment Agents:	Dalteparin	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	1- 2 weeks


Description/ Intervention:	The goal of this clinical research study is to learn about the risk of bleeding caused by the drug Fragmin (dalteparin) given to patients who have had surgical treatment for bone cancer.

Study Objectives / Outcomes

The primary endpoint of the study would be to determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopaedic oncology patients. Specifically, the goal of the study is to determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity. The study would help establish specific parameters for use of dalteparin in complex orthopaedic oncology patients. Not all patients would be appropriate for this medication, particularly those with massive hemorrhage during surgery and those with underlying coagulopathies. It is likely that patients requiring limited tumor excision, particularly those with metastatic carcinoma, would be ideal candidates for dalteparin therapy. Patients who require radical resections of tumor may need stricter guidelines for the safe use of the medication, since the potential for post-operative bleeding may be greater.

Study Status Information



Study Activation / Registration Date:	07/07/2006

IRB Review and Approval Date:	04/06/2005

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Group A: Metastatic disease, myeloma, lymphoma;

2) Group A: Pathologic fracture or impending pathologic fracture of the femur;

3) Group A: Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.

4) Group B: Primary sarcoma of bone or soft tissue of the lower extremity.

5) Group B: T2 tu;mor (>5 cm buty < 20 cm);

6) Group B: Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction.

Exclusion Criteria:

1) Presence of DVT on pre-operative screening ultrasound study

2) Massive tumor (> 20 cm in greatest dimension)

3) Amputation of the affected leg as treatment of tumor

4) Estimated blood loss > 2 liters during surgery

5) Surgical drain output > 500 cc of bloody fluid during first 8 hours

6) I.N.R. > 1.3 pre-operatively or > 1.5 post-operatively

7) Platelet count < 100,000 either pre-operatively or post-operatively

8) Indwelling post-operative epidural catheter for pain control

9) Age < 30 years

10) History of underlying bleeding disorder, such as hemophilia

11) History of adverse reaction to heparin such as heparin-induced thrombocytopenia

12) Severe liver or renal insufficiency

13) History of hypertensive or diabetic retinopathy

14) History of gastro-intestinal bleeding within 12 months

15) Treatment with warfarin, clopidogrel, aspirin, NSAIDs, LMWH or other anti-coagulants for conditions

16) History of stroke

17) Women of child bearing potential having a positive urine or serum pregnancy test (hCG) at the time of pre-operative evaluation (within 7 days of surgery)

18) Women who are breastfeeding

19) Hemoglobin < 8.0 g/dL

20) Platelet count < 100,000 /L

21) Alanine aminotransferase > 100 IU/L

22) Aspartate aminotransferase > 100 IU/L

23) Direct bilirubin > 0.5mg/dL

24) Serum creatinine > 2.0 mg/dL

25) Patients taking COX-2 inhibitors

26) Patients who have fragmented mechanical heart valves

Links

Registration Number: NCT00525057
Study Information on Clinical Trials Registry (clinicaltrials.gov)