Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

PHASE4COMPLETED

This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.

Study details:

Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA:. Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis).

Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30). Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses.

Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications
Age ≥70 years
ASA physical status 3 or 4
Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease
Obesity (BMI ≥30 kg/m2)
Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females)
Renal impairment (se. creatinine ≥150mol/l)
Low albumin (<30 g/L)

Exclusion criteria

Poor spoken and or written language comprehension
Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery
Pre-existing infection/sepsis
Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE4

Study ID

NCT04192435

Intervention or treatment

DRUG: Tranexamic Acid

DRUG: Placebos

Conditions

Infection Wound
Gastrointestinal Complication
Anesthesia
Bleeding
Healthcare Associated Infection

Condition: Infection Wound, Gastrointestinal Complication and more
DRUG: Tranexamic Acid and other drugs
Melbourne, Victoria, Australia
Sponsor: Bayside Health

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Research sites nearby

Closest Location:

Alfred Hospital

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Alfred Hospital
Melbourne, Victoria, Australia

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Who is running the clinical trial?

Bayside Health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Tranexamic acid At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.	Drug: Tranexamic Acid
PLACEBO_COMPARATOR: Placebo At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.	Drug: Placebos

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Incidence of Surgical Site Infection	defined by the US Centers for Disease Control (CDC)	from surgical incision to 30 days post surgical incision

Secondary Outcome

Measure	Description	Time Frame
Red cell transfusion	Total units given	from surgical incision to hospital discharge (from index surgery) or 30 days.
Other healthcare-associated infections	sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions	from surgical incision to 30 days
C-reactive protein	peak	Postoperative Day 3 (three days after surgical incision)
Days at home up to 30 days after surgery (DAH30).	Time that patient spends at home in the 30 days following surgery	From surgical incision to 30 days

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

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References

Clinical Trials Gov: Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

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