Clinical trial · Observational
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Crohn Disease | — | UNRESOLVED | — |
| Deep Vein Thrombosis | — | UNRESOLVED | — |
| Diverticular Diseases | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
| Venous Thromboses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D-dimer and lower limb venous duplex | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- UTMB's Colorectal Surgical Cohort
- description
- Subjects who meet the inclusion criteria that will have colorectal surgery at UTMB
- interventionNames
- Diagnostic Test: D-dimer and lower limb venous duplex
Primary outcomes (5)
- measure
- Observe the point prevalence of DVT's in preoperative colorectal patients at UTMB prior to having colorectal surgery.
- timeFrame
- 1 year
- description
- The data will be used to discover the prevalence of DVT prior to surgery and to establish DVT baseline rates at UTMB.
- measure
- Determine the incidence of postoperative DVT that occurred during the first 2 days of the inpatient stay that was discovered by a lower limb venous duplex
- timeFrame
- 1 year
- description
- Subjects will have a venous duplex on day two after surgery to look for a DVT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Colorectal cancer requiring surgical intervention-elective a)Benign or Malignant 2. Inflammatory colorectal conditions requiring surgical intervention-elective 1. Diverticulitis 2. Ulcerative Colitis 3. Crohn's Disease Exclusion Criteria: * Pregnancy * Emergency procedures
References
Publications (9)
- RESULTGarg R, Mohammed A, Singh A, Regueiro M, Click B. Trends and Outcomes of Acute Diverticulitis in Inflammatory Bowel Disease: A Propensity-matched National Study. Inflamm Bowel Dis. 2022 Jan 5;28(1):48-53. doi: 10.1093/ibd/izab017. PMID 33528011
- RESULTColorectal Writing Group for Surgical Care and Outcomes Assessment Program-Comparative Effectiveness Research Translation Network (SCOAP-CERTAIN) Collaborative; Nelson DW, Simianu VV, Bastawrous AL, Billingham RP, Fichera A, Florence MG, Johnson EK, Johnson MG, Thirlby RC, Flum DR, Steele SR. Thromboembolic Complications and Prophylaxis Patterns in Colorectal Surgery. JAMA Surg. 2015 Aug;150(8):712-20. doi: 10.1001/jamasurg.2015.1057. PMID 26060977
- RESULTRees PA, Clouston HW, Duff S, Kirwan CC. Colorectal cancer and thrombosis. Int J Colorectal Dis. 2018 Jan;33(1):105-108. doi: 10.1007/s00384-017-2909-2. Epub 2017 Nov 10. PMID 29127473
- RESULTStender MT, Frokjaer JB, Larsen TB, Lundbye-Christensen S, Thorlacius-Ussing O. Preoperative plasma D-dimer is a predictor of postoperative deep venous thrombosis in colorectal cancer patients: a clinical, prospective cohort study with one-year follow-up. Dis Colon Rectum. 2009 Mar;52(3):446-51. doi: 10.1007/DCR.0b013e318197e2b2. PMID 19333044
- RESULTBuchberg B, Masoomi H, Lusby K, Choi J, Barleben A, Magno C, Lane J, Nguyen N, Mills S, Stamos MJ. Incidence and risk factors of venous thromboembolism in colorectal surgery: does laparoscopy impart an advantage? Arch Surg. 2011 Jun;146(6):739-43. doi: 10.1001/archsurg.2011.127. PMID 21690452
- RESULTJohnson ED, Schell JC, Rodgers GM. The D-dimer assay. Am J Hematol. 2019 Jul;94(7):833-839. doi: 10.1002/ajh.25482. Epub 2019 Apr 19. PMID 30945756
- RESULTWeitz JI, Fredenburgh JC, Eikelboom JW. A Test in Context: D-Dimer. J Am Coll Cardiol. 2017 Nov 7;70(19):2411-2420. doi: 10.1016/j.jacc.2017.09.024.