Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.
Researchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.
Participants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
Follow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.
The rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.
At discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.
Second follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid and vitamin K | Experimental | 97 cirrhotic patients presenting with UGIB receiving tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24-48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy. |
|
| Placebo | Placebo Comparator | 97 cirrhotic patients presenting with UGIB receiving IV saline besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid and vitamin K | Drug | Tranxemic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection (10 mg daily of vitamin K for 24-48 h) along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients. Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate | The rate of rebleeding and need for blood transfusion at 5 days and 6 weeks will be evaluated and compared across the groups. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | The mortality rates at 5 days and 6 weeks will be evaluated and compared across the groups. | through study completion, an average of 1 year |
| adverse effects | Drug adverse effects at 5 days and 6 weeks will be evaluated and compared across the groups. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania M Elkafoury, MD | Contact | +201004672358 | rania.elkafoury@med.tanta.edu.eg | |
| Mennat-Allah M El Sawaf, MD | Contact | 00201225548976 | mennaallah.elsawaf@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rania M Elkafoury, MD | Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbyea | 31516 | Egypt |
Not provided
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005355 | Fibrosis |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D014812 | Vitamin K |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Intravenous saline over 24-48 hours along with initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy to control UGIB in cirrhotic patients. Patients will be followed up after 5 days and 6 weeks to assess the rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate. |
|
| through study completion, an average of 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D009285 |
| Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |