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

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02457403
• Collaborator: (none)
• Enrollment: 68
• Arms: 2
• Duration (Months): 43

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis; Coagulopathy	Device: ROTEM; Other: Conventional Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: 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
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ROTEM Transfusion guided by ROTEM during OLT	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.
Active Comparator: Conventional Transfusion guided by conventional labs	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.

Outcome Measures

Primary Outcome Measures

1. Intra-operative Blood Loss [Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).]

   Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.

Secondary Outcome Measures

1. Number of Participants With Bleeding Events [Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).]

   Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients 18 and older, admitted to the hospital

• Patients who have clinically documented cirrhosis

• Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000)

• Patients undergoing an endoscopic procedure or neurosurgical procedure

Exclusion Criteria:

• Patients must not be pregnant

• Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)

• Patients must not have an active infection (per PI discretion)

• Patients must not have any known hemostatic disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Adam J Hanje, MD, Assistant Professor-Clinical

Study Documents (Full-Text)

• Statistical Analysis Plan - Mar 10, 2020
• Study Protocol - Jan 9, 2017

More Information

Publications

None provided.

• Responsible Party: James Hanje, Associate Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT02457403
• Other Study ID Numbers: 2014H0487
• First Posted: May 29, 2015
• Last Update Posted: Jan 22, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Liver Cirrhosis; Hemostatic Disorders; Blood Coagulation Disorders; Fibrosis

Study Results

Participant Flow

Pre-assignment Detail	This is a prospective, single center, randomized clinical trial. 34 controls had transfusions guided by conventional labs and 34 participants had transfusions guided by ROTEM during orthotopic liver transplantation.

Arm/Group Title	ROTEM	Conventional
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	34	34
COMPLETED	34	34
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	ROTEM	Conventional	Total
Arm/Group Description	Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets & 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.	Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at < 100 mg/dL, 1 unit of cryoprecipitate was also transfused.	Total of all reporting groups
Overall Participants	34	34	68
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 100%	34 100%	68 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	13 38.2%	12 35.3%	25 36.8%
Male	21 61.8%	22 64.7%	43 63.2%
Race/Ethnicity, Customized (Count of Participants)
Race/Ethnicity : White	31 91.2%	31 91.2%	62 91.2%
Race/Ethnicity : Non-white	3 8.8%	3 8.8%	6 8.8%
Region of Enrollment (Count of Participants)
United States	34 100%	34 100%	68 100%
Indication for OLT (Count of Participants)
Count of Participants [Participants]	34 100%	34 100%	68 100%
Model for End-Stage Liver Disease Scale (MELD) score (units on a scale) [Mean (Standard Deviation) ]
ROTEM	25 (8.37)	25 (8.37)
Conventional	22 (7.70)	22 (7.70)
Presence of hepatocellular carcinoma (Count of Participants)
Count of Participants [Participants]	13 38.2%	10 29.4%	23 33.8%
Presence of portal vein thrombosis (Count of Participants)
Count of Participants [Participants]	4 11.8%	2 5.9%	6 8.8%
Presence of hypercoaguable state (Count of Participants)
Count of Participants [Participants]	0 0%	2 5.9%	2 2.9%

Outcome Measures

1. Primary Outcome

Title	Intra-operative Blood Loss
Description	Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.
Time Frame	Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ROTEM	Conventional
Arm/Group Description	Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets & 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.	Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at < 100 mg/dL, 1 unit of cryoprecipitate was also transfused.
Measure Participants	34	34
Median (Inter-Quartile Range) [milliliters]	2000	3000

2. Secondary Outcome

Title	Number of Participants With Bleeding Events
Description	Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months).
Time Frame	Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ROTEM	Conventional
Arm/Group Description	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.	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.
Measure Participants	34	34
Number [participants]	1 2.9%	0 0%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Standard definition from clinicaltrials.gov
Arm/Group Title	ROTEM		Conventional
Arm/Group Description	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.		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.
All Cause Mortality
	ROTEM		Conventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)
Serious Adverse Events
	ROTEM		Conventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	ROTEM		Conventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.