NCT02457403

Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy

A Prospective, Randomized Clinical Trial Comparing Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy: Rotational Thromboelastography (ROTEM) Versus Conventional Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).

Detailed description

Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.

Conditions

• Cirrhosis
• Coagulopathy

Interventions

Type	Name	Description
DEVICE	ROTEM	Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.
OTHER	Conventional Therapy	Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-11-01
• Completion: 2018-11-30
• First posted: 2015-05-29
• Last updated: 2021-01-22
• Results posted: 2021-01-22