Clinical trial NCT05246943: The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients
Official title: The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Venous Thromboses
Colorectal Cancer
Diverticular Diseases
Crohn Disease
Ulcerative Colitis
Deep Vein Thrombosis
Keywords: D-dimer
Colorectal Surgery
Thrombosis
DVT
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: 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. This study looks to enroll 100 subjects who meet inclusion criteria. The subjects will undergo screening for DVT using a lower limb bilateral venous duplex and a plasma D-dimer assay no longer than 10 days before their operation. This data will be used to observe the point prevalence of DVT's in preoperative colorectal subjects prior to having colorectal surgery. On the day of surgery, the subject will have a D-dimer test. After the operation, for next 2 days the subjects will have a daily D-dimer test and a lower limb bilateral venous duplex on the second day only. This data will determine the incidence of DVT's that were detected by lower limb bilateral venous duplex on inpatient stay day 2 and possibly indicated by an upward trending D-dimer value during the first 2 days of the inpatient stay. Approximately 2 weeks after surgery, at the postoperative clinic appointment, the subject will have a D-dimer assay and a lower limb bilateral venous duplex. This information will be used to determine the number of DVT events in postoperative colorectal hospitalized subjects that were on the D-dimer monitoring protocol. The D-dimer assay detects the presence of fibrin degradation products, which may indicate a fibrin blood clot in the body.6 A maximum of 5 milliliters of blood will be collected for each D-dimer test. If a DVT is detected by the gold standard method which is a bilateral lower limb duplex during any point of study, the subject will be treated as per standard of care at UTMB by the colorectal surgical team

Eligibility criteria: 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

Primary outcomes:
measure: Observe the point prevalence of DVT's in preoperative colorectal patients at UTMB prior to having colorectal surgery.
timeFrame: 1 year
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
measure: Compare the number of DVT events in postoperative hospitalized patients that were on the D-dimer monitoring protocol.
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Uma Phatak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
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citation: 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.