This study aims to provide a comprehensive assessment of global coagulation parameters in patients with ASC both in hospital and up to 12 weeks after discharge. The results will help define the period at risk for VTE and inform the rationale for…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To provide a comprehensive assessment of the haemostatic profile of patients
with acute severe colitis (ASC) during hospitalization and up to 12 weeks
post-discharge from hospital (page 12).
Secondary outcome
1. To identify biomarkers of a pro-thrombotic state in patients with ASC that
could be used to identify patients at highest risk of VTE, to guide the
duration of thromboprophylaxis and monitor response to treatment.
2. To inform the need for clinical studies of extended thromboprophylaxis for
patients with ASC after discharge from hospital
Background summary
Venous thromboembolism (VTE) is a disease specific extra-intestinal
manifestation of Inflammatory Bowel Disease (IBD). Its mechanisms are poorly
understood but are probably multifactorial with potentially fatal consequences.
Whilst guidelines support the use of thromboprophylaxis in hospitalised
patients with acute severe colitis (ASC), this is not advocated after discharge
and population-based studies suggest that this may be the period of great risk
for developing VTE. This study aims to provide a comprehensive assessment of
global coagulation parameters in patients with ASC both in hospital and up to
12 weeks after discharge. The results will help define the period at risk for
VTE and inform the rationale for clinical studies to examine the need for
extended thromboprophylaxis after discharge from hospital with ASC.
Study objective
This study aims to provide a comprehensive assessment of global coagulation
parameters in patients with ASC both in hospital and up to 12 weeks after
discharge. The results will help define the period at risk for VTE and inform
the rationale for clinical studies to examine the need for extended
thromboprophylaxis after discharge from hospital with ASC.
Study design
Prospective case-control study
Study burden and risks
Intervention: Blood sampling at day 1 and 5 of admission then at 4 week & weeks
8-12 post discharge clinic follow up, alongside routine blood sampling.
The risks of blood sampling are limited to potential bruising and discomfort at
the site of venepuncture. The patient population is unlikely to have
complications related to the extra volume of blood drawn. The 21ml blood draw
(equivalent to two tablespoons), is minimal compared to the total circulating
blood volume (~5 litres).
Headly Way
Headington OX3 9DU
NL
Headly Way
Headington OX3 9DU
NL
Listed location countries
Age
Inclusion criteria
* Male or Female, aged 18 years or above;* Cases:
o Adult patients with ASC (Montreal S3 as defined by passage of *6 bloody stools daily with one or more of the following: heart rate *90 bpm, temperature * 37.8°C (99.5°F), haemoglobin level of <105g/L (10.5 g/dL), ESR *30 mm/hour or CRP*45;* Controls:
o Adult patients attending the outpatient setting with extensive UC (Montreal E3 as defined by involvement extending proximal to the splenic flexure) in clinical remission (Montreal S0, asymptomatic).;* Volunteers:
o Healthy adult volunteers with no history of IBD
Exclusion criteria
* Age < 18 years
* Previous history of VTE
* Known thrombophilia
* Anti-coagulant treatment
* Anti-platelet treatment
* Liver cirrhosis
* Recent thrombolytic therapy (<2 weeks)
* Antifibrinolytic treatment
* Pregnant or breastfeeding women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49897.018.14 |