Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Hepatectomy, Surgical Blood Loss, Terlipressin Clinical Trial

Official title:

Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588716
• Other study ID #: Terlipressin
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2015
• Last updated: December 23, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in cirrhotic patients undergoing major liver resections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

Exclusion Criteria:

• Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Hepatectomy, Surgical Blood Loss, Terlipressin

Intervention

Drug:
• Terlipressin
Terlipressin will be given as an intravenous injection of 2µg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.
• normal saline
Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss	blood loss in ml	intraoperative period
Secondary	blood units transfused	number of packed RBCs units transfused	intraoperative period
Secondary	lactate level	lactate level in blood gas sample in mmol/L	at start and end of resection