Overview

Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
Summary
Hypotheses: H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls. H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification. H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Walter Reed National Military Medical Center
Treatments:
Celecoxib
Criteria
Inclusion Criteria:

1. ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)

2. Extremity Wound ≥75cm2 requiring operative intervention

3. Minimal age of 18 years

Exclusion Criteria:

The following co-morbidities will result in exclusion from study:

1. Coronary Artery Disease,

2. Diabetes Mellitus (IDDM or T2DM),

3. Peripheral Vascular Disease,

4. Age >65,

5. Connective tissue disorders,

6. Immunosuppression,

7. Clinically-evident peptic ulcer disease,

8. Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated
creatinine clearance of <50),

9. Spine-injured patients who have recently received or are going to receive spinal
fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at
LRMC,

10. Severe penetrating or hemorrhagic traumatic brain injury,

11. Endoscopic gastrointestinal interventions,

12. Pregnancy or women of childbearing who does not take a pregnancy test and effective
method of birth control.

13. Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.

14. History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other
NSAIDs.

15. Hepatic Impairment

16. Warfarin

17. Lithium

18. Drugs known to inhibit CYP2C9 Liver Enzymes

19. Subjects known or suspected to be poor CYP2C9 metabolizers

20. Concomitant use with ACE Inhibitors and Angiotension II Antagonists