Procedure Outcome Predictor (POP) Using the Complement Cascade
CPOP
1 other identifier
observational
45
0 countries
N/A
Brief Summary
Current post-operative monitoring of patient recovery consists measuring two blood markers C-reactive protein (CRP) and White Blood Cell Count (WBC). However, these are slow to respond to the onset of infection. However, monitoring the absolute levels of the proteins in the three pathways of the complement cascade should provide a faster and better predictor of patient recovery. The investigators propose a pilot trial to measure concentrations of Complement Cascade (CC) activation biomarkers in the blood over a time course around operations of major abdomino-pelvic surgery involving a bowel resection. Further, analysis of the differential CC pathway activation should identify the onset of recovery complications before clinical symptoms present and potentially identify the causes allowing the clinicians to target therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2010
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedAugust 24, 2015
August 1, 2015
3 months
August 5, 2015
August 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of the Complement Activation with descriptive statistics to establish the size of an effect for a larger prospective cohort study
The study will determine Complement Cascade activation for a cohort of 45 patients receiving elective colorectal surgery. C3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours.
5 days
Study Arms (1)
Observation
45 patients receiving elective colorectal surgery
Interventions
C3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours.
Eligibility Criteria
45 patients receiving elective colorectal surgery
You may qualify if:
- Elective surgery list of pelvic oncology surgeons
You may not qualify if:
- Unable/unwilling to provide informed consent
- Pregnant women
- Under 18 years of age
- Pre-existing active infection
- Diabetic
- Inflammatory bowel disorders
- Immunosuppressed
- Immunosuppression or steroid treatment within the last 12 months
- Learning disability or mental health problems
- Non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Exeterlead
- Royal Devon and Exeter NHS Foundation Trustcollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew M Shaw, PhD
University of Exeter
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 24, 2015
Study Start
November 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
August 24, 2015
Record last verified: 2015-08