The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

NCT05246943 | Withdrawn DMC

• 1 other identifier: 21-0266
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Venous Thromboses; Colorectal Cancer; Diverticular Diseases; Crohn Disease; Ulcerative Colitis; Deep Vein Thrombosis

Keywords

D-dimer; Colorectal Surgery; Thrombosis; DVT

Outcome Measures

Primary Outcomes (5)

• Observe the point prevalence of DVT's in preoperative colorectal patients at UTMB prior to having colorectal surgery.

  The data will be used to discover the prevalence of DVT prior to surgery and to establish DVT baseline rates at UTMB.

  1 year

• 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

  Subjects will have a venous duplex on day two after surgery to look for a DVT

  1 year

• Compare the number of DVT events in postoperative hospitalized patients that were on the D-dimer monitoring protocol.

  The data will be used to determine the number of DVT's that were discovered in the subject population and to establish baseline rates of DVT after surgery and hospital discharge

  1 year

• Determine if there is a statistical difference between the D-dimer value of patients with DVT prior to surgery compared to patients who develop DVT after surgery

  This data will be used to compare the D-dimer values in subjects that had DVT prior to surgery to those who developed a postoperative DVT while inpatient or at the postoperative clinic appointment

  1 year

• Compare the D-dimer results of DVT positive subjects to DVT negative subjects to identify a specific result range seen in the DVT positive subjects.

  These results will be used as preliminary evidence for future research to determine if revised D-dimer cut off values can be diagnostic in conditions known to have low test specificity

  1 year

Study Arms (1)

UTMB's Colorectal Surgical Cohort

Subjects who meet the inclusion criteria that will have colorectal surgery at UTMB

Diagnostic Test: D-dimer and lower limb venous duplex

Interventions

D-dimer and lower limb venous duplex DIAGNOSTIC_TEST

D-dimer blood test- The D-dimer assay detects the presence of fibrin degradation products, which can indicate the breakdown of a fibrin clot Lower Limb Venous Duplex- Using an ultrasound to visually look for a clot

UTMB's Colorectal Surgical Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB.

You may qualify if:

• Colorectal cancer requiring surgical intervention-elective
• a)Benign or Malignant
• Inflammatory colorectal conditions requiring surgical intervention-elective
• Diverticulitis
• Ulcerative Colitis
• Crohn's Disease

You may not qualify if:

• Pregnancy
• Emergency procedures

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Related Publications (9)

• Garg 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 RESULT

• Colorectal 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 RESULT

• Rees 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 RESULT

• Stender 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 RESULT

• Buchberg 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 RESULT

• Johnson 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 RESULT

• Weitz 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.

  PMID: 29096812 RESULT

• Tassiopoulos AK, Mofakham S, Rubano JA, Labropoulos N, Bannazadeh M, Drakos P, Volteas P, Cleri NA, Alkadaa LN, Asencio AA, Oganov A, Hou W, Rutigliano DN, Singer AJ, Vosswinkel J, Talamini M, Mikell CB, Kaushansky K. D-Dimer-Driven Anticoagulation Reduces Mortality in Intubated COVID-19 Patients: A Cohort Study With a Propensity-Matched Analysis. Front Med (Lausanne). 2021 Feb 4;8:631335. doi: 10.3389/fmed.2021.631335. eCollection 2021.

  PMID: 33634153 RESULT

• Jiang Y, Li J, Liu Y, Zhang W. Diagnostic accuracy of deep vein thrombosis is increased by analysis using combined optimal cut-off values of postoperative plasma D-dimer levels. Exp Ther Med. 2016 May;11(5):1716-1720. doi: 10.3892/etm.2016.3125. Epub 2016 Mar 2.

  PMID: 27168793 RESULT

MeSH Terms

Conditions

Venous Thrombosis; Colorectal Neoplasms; Diverticular Diseases; Crohn Disease; Colitis, Ulcerative; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis

Study Officials

• Uma Phatak, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: May 25, 2022
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04