Upper Digestive BleedingPhase 4EXARHOSENCT03023189
Efficacity and Safety of Tranexamic Acid in Cirrhotic Patients Presenting With Acute Upper Gastrointestinal Bleeding
A Phase 4 study testing Tranexamic acid in people with Upper Digestive Bleeding and Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Upper digestive bleeding. Upper gastrointestinal haemorrhage is a common cause of decompensated cirrhosis and is associated with a high mortality rate among cirrhotic patients. Its leading cause is the rupture of gastro-esophageal varices due to portal hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Digestive Bleeding, Cirrhosis
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Apr 2017to Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patient treated by a prehospital physician-staffed SMUR team, a firefighter physician-staffed ambulance (ARBSPP), an hospital EMS or an ICU
- Acute upper digestive bleeding (< 24h) in the shape of hematemesis, described either by the physician, the patient, a relative or a member of the medical team
- Known or suspected cirrhosis (based on clinical/biological/radiographic/anamnestic data)
- Affiliated or recipient of the French social security
- Written consent (or under emergency procedures)
Who cannot join
- Known ongoing pregnancy or breastfeeding
- TA already given (if inter-hospital transfer)
- Endoscopy already performed for the current haemorrhagic episode
- Hospitalization for over 24h in an intensive care unit or a routine care unit
- Exclusive lower digestive bleeding or melena only
- Patient in cardiac arrest at the arrival of the prehospital medical team, whether recovered or not
Show all 16Show fewer
- Patient already randomised once in EXARHOSE study
- TA Counter-indications
- creatininemia > 500 μmol/L or documented clearance < 30 mL/min
- documented ongoing CIVD (prior to UDB)
- ongoing seizures
- ongoing arterial or venous thrombosis
- allergy
- Known participation of the patient to another therapeutic study
- Known linguistic inability of the patient to understand the study
- Patient under known guardianship
Trial locations and contacts
3 sites in 1 country.
Matthieu HEIDET, MD contact
Roland AMATHIEU, MD contact
France3 sites, 3 recruiting
- Recruiting
Jean Verdier Hospital
Bondy, 93140
Roland Amathieu, MD, roland.amathieu@aphp.fr
- Recruiting
Henri Mondor Hospital
Créteil, 94010
Matthieu HEIDET, MD, matthieu.heidet@aphp.fr
- Recruiting
Marc Jacquet Hospital
Melun, 77000
Line JACOB, MD, line.jacob@ch-melun.fr
About this study
Official title: Efficacy and Safety of Early Administration of Tranexamic Acid in Cirrhotic Patients Presenting With Acute Upper Gastrointestinal Bleeding: a Multicenter, Randomized, Double Blind, Placebo-controlled Trial (Modified by amendment1)
Upper digestive bleeding. Upper gastrointestinal haemorrhage is a common cause of decompensated cirrhosis and is associated with a high mortality rate among cirrhotic patients. Its leading cause is the rupture of gastro-esophageal varices due to portal hypertension. In cirrhotic patients, the management of acute gastrointestinal haemorrhage is challenging as they often present with coagulation (or haemostasis abnormalities) abnormalities such as hyperfibrinolysis, especially when the cirrhosis is decompensated. Beyond life support measures, therapeutic modalities of upper gastrointestinal bleeding rely on both endoscopic and pharmacological interventions. Tranexamic acid (TA) is an antifibrinolytic that may help control the bleeding in this setting, as it showed an unquestionable benefit in other indications. TA has previously been studied in both upper gastrointestinal haemorrhage from any causes and in liver transplantation of cirrhotic patients. However, there is a lack of data to conclude on its effectiveness (or efficiency) in the early treatment of acute bleeding in cirrhotic patients.
Investigators hypothesize that, when given early, TA would be beneficial for cirrhotic patients presenting with acute upper gastrointestinal haemorrhage , by controlling the haemorrhage, avoiding rebleeding episodes and reducing mortality within 5 days after its administration. Moreover, TA could prevent early cirrhosis complications (such as hepatic encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), could reduce indications to transjugular portosystemic shunt (TIPS), shorten the length of stay in intensive care unit and the length of hospitalization, and decrease late relapses and one-year mortality.
Read the detailed description
Acute Upper gastrointestinal haemorrhage (UGIH) is frequent, with an estimated annual incidence of 150/100 000 in France. Its second etiology is the rupture of portal hypertension-related gastro-esophageal varices, accounting for 20 % of the patients and responsible for more than 50 % of the hospitalizations in intensive care unit (ICU) for UGIH.
In cirrhotic patients, variceal bleeding is the main cause of UGIH (over 70 %) and death (30 %), which occurs in the most severe patients (Child-Pugh score B or C and/or high MELD score, and high levels of portal hypertension).
Acute UGIH is directly responsible for 50 % of the deaths, either because it remains uncontrolled during the acute phase (within 5 days), or because of early relapses (within 6 weeks). Every episode of acute UGIH worsens the middle and long-term vital prognosis: about 60 % of the patients present with UGIH recurrence within one year and the survival rate is only 30 % 3 years after the first episode.
Moreover, acute UGIH is a triggering factor for several severe cirrhosis-specific complications (such as hepatic encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), which themselves lead to high mortality rates. Despite the improvement of preventive, diagnostic and therapeutic strategies, UGIH remains stable in France.
The haemostasis of cirrhotic patients is often abnormal at baseline : thrombopenia, decrease of factors II, V, VII, IX, X and XI, decrease of fibrinolytic proteins, increase of factor VIII and spontaneous fibrinolysis. When compensated, the cirrhotic's haemostasis remains globally preserved, due to the balance of pro and anticoagulant alterations.
Every cause of cirrhosis decompensation, such as acute PHT-UGIH, can increase hemostatic disorders, leading to hyperfibrinolysis. This could slow down or inhibit the clotting, thus disrupting pharmacological control of acute UGIH.
TA could be efficient in acute UGIH of cirrhotic patients. It is a simple antifibrinolytic which showed clinical benefits on haemorrhage and/or mortality in several other indications (surgical, obstetrical and traumatic). It is now widely used according to recommendations.
Early administration of TA seems to be beneficial in UGIH haemorrhage. Despite theoretical efficiency, 4 recent Cochrane meta-analysis concluded to the lack of significant data (poor overall trials quality). The benefit of the use of TA in acute UGIH (and acute PHT-UGIH) remains uncertain.
At this day, TA has still not been studied in acute UGIH of cirrhotic patients, although it showed benefits on blood transfusion's requirements and on haemorrhagic complications during liver transplantation (for which cirrhosis most frequent cause).
- Conditions
- Upper Digestive Bleeding, Cirrhosis
- Being tested
- Tranexamic acid, Placebo
- Keywords
- Upper digestive bleeding, Haemorrhage, Cirrhosis, Antifibrinolytic, Tranexamic acid, Emergency
- Medical subject headings
- Fibrosis, Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
At randomisation : loading dose of 1g of intravenous tranexamic acid for 10 min, immediately followed by an intravenous infusion of 3g of TA over 24h.
Total dose : 4 g of TA
PlaceboDrug
At randomisation : loading dose of 10 mL of intravenous isotonic saline for 10 min, immediately followed by an intravenous infusion of 30 mL of isotonic saline over 24h Total dose : 40 mL of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | At randomisation : loading dose of 1g of intravenous tranexamic acid for 10 min, immediately followed by an intravenous infusion of 3g of TA over 24h Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | At randomisation : loading dose of 10 mL of intravenous isotonic saline for 10 min, immediately followed by an intravenous infusion of 30 mL of isotonic saline over 24h Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome is a composite criterion and includes: control on acute bleeding, absence of re-bleeding episodes at day 5 and absence of death at day 5 (modified by amendment 1)
Specifically, the composite criterion is defined by all the following criteria:
- Immediate control of the hemorrhage after initial patient management using splanchnic vasoconstrictors and/or proton pump inhibitors, potentially including volume expander, transfusion and/or prescription of vasopressor amines :
- Achievement of the transfusion target (Hb ≥ 7 g/dL) 24 hours after initial patient management and then until day 5
- Absence of initiation or increase in vasopressor amines, until day 5
- Absence of recourse to the transfusion of 2 or more red cells packs within 24h to maintain the transfusion target (Hb ≥ 7 g/dL)
- Absence of persistence or evolution towards haemorrhagic shock (systolic blood pressure < 100 mmHg and/or mean arterial pressure < 60 mmHg and/or heart rate > 100 bpm)
- Absence of re-bleeding episodes at day 5, assessed by the medical team on the bases of clinical, biological or endoscopic elements
- Absence of death at day 5
Measured: 5 days after randomisation
Secondary outcomes (15)
Control of the bleeding
At least 1 criterion present :
- Persistence of the bleeding (regardless of the volume), 2 hours after initiation of medical or endoscopic treatment
- And/Or blood transfusion needed within 24 hours after treatment initiation (≥ 2 red cells units)
- And/Or hemorrhagic shock installation (systolic blood pressure < 100 mmHg and/or mean arterial pressure < 60 mmHg and/or heart rate > 100 bpm)
Measured: Within 5 days after randomisation
Re-bleeding episodes
Measured: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Death
Measured: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Fluid infusion volume (in mL)
Measured: At day 6, day 28 and day 42 after randomisation
Blood transfusion volume (in mL)
Measured: At day 6, day 28 and day 42 after randomisation
Blood transfusion quantity (number of units)
Measured: At day 6, day 28 and day 42 after randomisation
Nature of blood transfusion: - Red cells units - Platelets units - Fresh frozen plasma - Fibrinogen - Other
Measured: At day 6, day 28 and day 42, after randomisation
TIPS procedure (in Child-Pugh B patients)
Measured: At day 6, day 28, day 42 after randomisation
Visceral and systemic complications
Complications, defined as:
- Acute organ failure (using CLIF-C ACLF and CLIF-SOFA scores)
- Hepatic encephalopathy
- Hepatic failure
- Hepatorenal syndrome
- Renal failure (using grades 2 and 3 of the KDIGO classification)
- Sepsis
- Ascites liquid infection
Measured: At day 6, day 28 and day 42, after randomisation (or until discharge)
Need for organ substitution - Renal replacement therapy (dialysis) - Liver replacement therapy - Mechanical ventilation
Measured: At day 6, day 28 and day 42, after randomisation (or until discharge)
Liver transplantation
Measured: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Length of stay in ICU (in days)
Measured: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Duration of hospitalization (in days)
Measured: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Number of participants with treatment-related adverse events as assessed by the ANSM notice of Exacyl®
Adverse events as assessed by the ANSM notice of Exacyl® are :
- Allergy
- Thrombotic events
- Seizures
- Acute renal failure (KDIGO grades 2 and 3)
- Death
- Or any other adverse event suspected to be treatment-related
Adverse effects will be systematically searched for and collected in the electronic Case Report Form (eCRF) during the acute phase (within 5 days after randomization), as assessed by the AP-HP notification form. When present, investigators will have to send a notification to the promoter (by fax). Patients with severe adverse effects (leading to death, life-threatening condition, hospitalization and pursuit of hospitalization, incapacity or handicap, congenital malformation) will be followed until disappearance of these. Every document related to the patient during the protocol should be transmitted to the promoter. Investigators are supposed to answer every inquiry of the promoter.
Measured: up to 5 days
Delay between the beginning of the haemorrhage and the initiation of the AT treatment
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start3 Apr 2017
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Digestive BleedingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu HEIDET, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023189
- Sponsor's protocol ID
- P150959
- Other IDs
- 2016-002677-35, 2016
- Acronym
- EXARHOSE
- Status last verified
- Apr 2018
- First submitted
- 23 Dec 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heidet M, Amathieu R, Audureau E, Augusto O, Nicolazo de Barmon V, Rialland A, Schmitz D, Pierrang F, Marty J, Chollet-Xemard C, Thirion O, Jacob L. Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding: a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study). BMJ Open. 2018 Aug 10;8(8):e021943. doi: 10.1136/bmjopen-2018-021943.
PubMed 30099397Heidet M, Mermet E, Vaux J, Jeremie R, Audureau E, Marty J. Simulated EMS response times until patients located in public train stations: A geospatial model to improve on-foot accessibility. Resuscitation. 2018 Oct;131:e3-e5. doi: 10.1016/j.resuscitation.2018.07.031. Epub 2018 Aug 2. No abstract available.
PubMed 30077741
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early Administration of Tranexamic Acid in Cirrhotic Patients Presenting With Acute Upper Gastrointestinal Bleeding: a Multicenter, Randomized, Double Blind, Placebo-controlled Trial (Modified by amendment1)
- ClinicalTrials.gov ID
- NCT03023189
- Acronym / sponsor ID
- EXARHOSE / P150959
- Conditions
- Upper Digestive Bleeding, Cirrhosis
- Keywords
- Upper digestive bleeding, Haemorrhage, Cirrhosis, Antifibrinolytic, Tranexamic acid, Emergency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper digestive bleeding. Upper gastrointestinal haemorrhage is a common cause of decompensated cirrhosis and is associated with a high mortality rate among cirrhotic patients. Its leading cause is the rupture of gastro-esophageal varices due to portal hypertension. In cirrhotic patients, the management of acute gastrointestinal haemorrhage is challenging as they often present with coagulation (or haemostasis abnormalities) abnormalities such as hyperfibrinolysis, especially when the cirrhosis is decompensated. Beyond life support measures, therapeutic modalities of upper gastrointestinal bleeding rely on both endoscopic and pharmacological interventions. Tranexamic acid (TA) is an antifibrinolytic that may help control the bleeding in this setting, as it showed an unquestionable benefit in other indications. TA has previously been studied in both upper gastrointestinal haemorrhage from any causes and in liver transplantation of cirrhotic patients. However, there is a lack of data to conclude on its effectiveness (or efficiency) in the early treatment of acute bleeding in cirrhotic patients.
Investigators hypothesize that, when given early, TA would be beneficial for cirrhotic patients presenting with acute upper gastrointestinal haemorrhage , by controlling the haemorrhage, avoiding rebleeding episodes and reducing mortality within 5 days after its administration. Moreover, TA could prevent early cirrhosis complications (such as hepatic encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), could reduce indications to transjugular portosystemic shunt (TIPS), shorten the length of stay in intensive care unit and the length of hospitalization, and decrease late relapses and one-year mortality.
Detailed description
Acute Upper gastrointestinal haemorrhage (UGIH) is frequent, with an estimated annual incidence of 150/100 000 in France. Its second etiology is the rupture of portal hypertension-related gastro-esophageal varices, accounting for 20 % of the patients and responsible for more than 50 % of the hospitalizations in intensive care unit (ICU) for UGIH.
In cirrhotic patients, variceal bleeding is the main cause of UGIH (over 70 %) and death (30 %), which occurs in the most severe patients (Child-Pugh score B or C and/or high MELD score, and high levels of portal hypertension).
Acute UGIH is directly responsible for 50 % of the deaths, either because it remains uncontrolled during the acute phase (within 5 days), or because of early relapses (within 6 weeks). Every episode of acute UGIH worsens the middle and long-term vital prognosis: about 60 % of the patients present with UGIH recurrence within one year and the survival rate is only 30 % 3 years after the first episode.
Moreover, acute UGIH is a triggering factor for several severe cirrhosis-specific complications (such as hepatic encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), which themselves lead to high mortality rates. Despite the improvement of preventive, diagnostic and therapeutic strategies, UGIH remains stable in France.
The haemostasis of cirrhotic patients is often abnormal at baseline : thrombopenia, decrease of factors II, V, VII, IX, X and XI, decrease of fibrinolytic proteins, increase of factor VIII and spontaneous fibrinolysis. When compensated, the cirrhotic's haemostasis remains globally preserved, due to the balance of pro and anticoagulant alterations.
Every cause of cirrhosis decompensation, such as acute PHT-UGIH, can increase hemostatic disorders, leading to hyperfibrinolysis. This could slow down or inhibit the clotting, thus disrupting pharmacological control of acute UGIH.
TA could be efficient in acute UGIH of cirrhotic patients. It is a simple antifibrinolytic which showed clinical benefits on haemorrhage and/or mortality in several other indications (surgical, obstetrical and traumatic). It is now widely used according to recommendations.
Early administration of TA seems to be beneficial in UGIH haemorrhage. Despite theoretical efficiency, 4 recent Cochrane meta-analysis concluded to the lack of significant data (poor overall trials quality). The benefit of the use of TA in acute UGIH (and acute PHT-UGIH) remains uncertain.
At this day, TA has still not been studied in acute UGIH of cirrhotic patients, although it showed benefits on blood transfusion's requirements and on haemorrhagic complications during liver transplantation (for which cirrhosis most frequent cause).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic acidAt randomisation : loading dose of 1g of intravenous tranexamic acid for 10 min, immediately followed by an intravenous infusion of 3g of TA over 24h |
| Placebo | Placebo comparator | Drug: PlaceboAt randomisation : loading dose of 10 mL of intravenous isotonic saline for 10 min, immediately followed by an intravenous infusion of 30 mL of isotonic saline over 24h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- Patient treated by a prehospital physician-staffed SMUR team, a firefighter physician-staffed ambulance (ARBSPP), an hospital EMS or an ICU
- Acute upper digestive bleeding (< 24h) in the shape of hematemesis, described either by the physician, the patient, a relative or a member of the medical team
- Known or suspected cirrhosis (based on clinical/biological/radiographic/anamnestic data)
- Affiliated or recipient of the French social security
Key exclusion criteria (16 listed)
- Known ongoing pregnancy or breastfeeding
- TA already given (if inter-hospital transfer)
- Endoscopy already performed for the current haemorrhagic episode
- Hospitalization for over 24h in an intensive care unit or a routine care unit
- Exclusive lower digestive bleeding or melena only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAt randomisation : loading dose of 1g of intravenous tranexamic acid for 10 min, immediately followed by an intravenous infusion of 3g of TA over 24h. Total dose : 4 g of TA | Drug | Tranexamic acid |
| PlaceboAt randomisation : loading dose of 10 mL of intravenous isotonic saline for 10 min, immediately followed by an intravenous infusion of 30 mL of isotonic saline over 24h Total dose : 40 mL of Placebo | Drug | Placebo |
Primary outcome
The main outcome is a composite criterion and includes: control on acute bleeding, absence of re-bleeding episodes at day 5 and absence of death at day 5 (modified by amendment 1)
Time frame: 5 days after randomisation
Specifically, the composite criterion is defined by all the following criteria: * Immediate control of the hemorrhage after initial patient management using splanchnic vasoconstrictors and/or proton pump inhibitors, potentially including volume expander, transfusion and/or prescription of vasopressor amines : * Achievement of the transfusion target (Hb ≥ 7 g/dL) 24 hours after initial patient management and then until day 5 * Absence of initiation or increase in vasopressor amines, until day 5 * Absence of recourse to the transfusion of 2 or more red cells packs within 24h to maintain the transfusion target (Hb ≥ 7 g/dL) * Absence of persistence or evolution towards haemorrhagic shock (systolic blood pressure < 100 mmHg and/or mean arterial pressure < 60 mmHg and/or heart rate > 100 bpm) * Absence of re-bleeding episodes at day 5, assessed by the medical team on the bases of clinical, biological or endoscopic elements * Absence of death at day 5
15 secondary outcomes
Control of the bleeding
Time frame: Within 5 days after randomisation
Re-bleeding episodes
Time frame: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Death
Time frame: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Fluid infusion volume (in mL)
Time frame: At day 6, day 28 and day 42 after randomisation
Blood transfusion volume (in mL)
Time frame: At day 6, day 28 and day 42 after randomisation
Blood transfusion quantity (number of units)
Time frame: At day 6, day 28 and day 42 after randomisation
Nature of blood transfusion: - Red cells units - Platelets units - Fresh frozen plasma - Fibrinogen - Other
Time frame: At day 6, day 28 and day 42, after randomisation
TIPS procedure (in Child-Pugh B patients)
Time frame: At day 6, day 28, day 42 after randomisation
Visceral and systemic complications
Time frame: At day 6, day 28 and day 42, after randomisation (or until discharge)
Need for organ substitution - Renal replacement therapy (dialysis) - Liver replacement therapy - Mechanical ventilation
Time frame: At day 6, day 28 and day 42, after randomisation (or until discharge)
Liver transplantation
Time frame: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Length of stay in ICU (in days)
Time frame: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Duration of hospitalization (in days)
Time frame: At day 6, day 28, day 42, 3 months, 6 months and 1 year after randomisation
Number of participants with treatment-related adverse events as assessed by the ANSM notice of Exacyl®
Time frame: up to 5 days
Delay between the beginning of the haemorrhage and the initiation of the AT treatment
Time frame: At day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Derived from this study: PubMed 30099397Heidet M, Amathieu R, Audureau E, Augusto O, Nicolazo de Barmon V, Rialland A, Schmitz D, Pierrang F, Marty J, Chollet-Xemard C, Thirion O, Jacob L. Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding: a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study). BMJ Open. 2018 Aug 10;8(8):e021943. doi: 10.1136/bmjopen-2018-021943.
- Derived from this study: PubMed 30077741Heidet M, Mermet E, Vaux J, Jeremie R, Audureau E, Marty J. Simulated EMS response times until patients located in public train stations: A geospatial model to improve on-foot accessibility. Resuscitation. 2018 Oct;131:e3-e5. doi: 10.1016/j.resuscitation.2018.07.031. Epub 2018 Aug 2. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu HEIDET, MD contact
Roland AMATHIEU, MD contact
Matthieu HEIDET principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid in people with Upper Digestive Bleeding and Cirrhosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu HEIDET, MD (matthieu.heidet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome is a composite criterion and includes: control on acute bleeding, absence of re-bleeding episodes at day 5 and absence of death at day 5 (modified by amendment 1) (time frame: 5 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023189, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.