Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection

NCT00902343 | Completed Phase 3

• 1 other identifier: 08-158
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn the best method of assigning patients to receive "acute normovolemic hemodilution" during liver surgery.

Conditions

Liver Cancer

Keywords

Liver; Cancer; Primary; Metastatic; transfusions; 08-158

Outcome Measures

Primary Outcomes (1)

• To determine if nomogram-based allocation of ANH is superior to allocation using extent of resection alone (planned resection of 3 or more liver segments) in patients undergoing partial hepatectomy.

  during surgery

Secondary Outcomes (1)

• To assess the impact of nomogram-based allocation of ANH compared to standard allocation on the need for fresh frozen plasma (FFP) transfusions.

  during surgery

Study Arms (2)

1

EXPERIMENTAL

nomogram-based selection for acute normovolemic hemodilution

Procedure: nomogram-based selection for acute normovolemic hemodilution

2

ACTIVE COMPARATOR

standard selection for ANH based on a planned resection of 3 or more segments.

Procedure: standard selection for ANH based on a planned resection of 3 or more segments

Interventions

nomogram-based selection for acute normovolemic hemodilution PROCEDURE

Will use the nomogram to determine whether or not the patient needs ANH during surgery. The nomogram assigns a point value to certain pre-op factors to determine whether or not the patient will need an ANH. Preoperative factors that will be used are platelet count, planned amount of liver to be removed, hemoglobin level, if the surgeon needs to operate on any organ outside of the liver to remove the tumor, and the patients health overall.

Also known as: The actual operation to remove the tumor will be the same for both groups,, and in fact will be done the same way as it is done for patients who are not, in this study.

1

standard selection for ANH based on a planned resection of 3 or more segments PROCEDURE

Will use the planned amount of liver to be removed to determine whether or not the patient needs an ANH during surgery.

Also known as: The actual operation to remove the tumor will be the same for both groups,, and in fact will be done the same way as it is done for patients who are not, in this study.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years).
• Preoperative hemoglobin concentration ≥ 11 mg/dl (males), ≥ 10 mg/dl (females) within 14 days of registration.
• Patients scheduled for hepatic resection for any indication, with or without other planned procedures

You may not qualify if:

• A history of active coronary artery disease.
• Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 30 days of operation.
• Patients with active or symptomatic cerebrovascular disease; patients with hemodynamically insignificant stenosis will not be deemed ineligible.
• A history of congestive heart failure.
• A history of uncontrolled hypertension.
• A history of restrictive or obstructive pulmonary disease.
• A history of renal dysfunction (Cr \> 1.8).
• Abnormal coagulation parameters (INR \> 1.5 in patients not on coumadin; an INR\>1.5 is acceptable in patients still on coumadin, provided drug is discontinued no less than 4 days prior to operation.)
• Presence of active infection.
• Evidence of hepatic metabolic disorder (bilirubin \> 2 mg/dl, ALT \> 75 U/L in the absence of biliary tract obstruction).
• Pre-operative autologous blood donation.
• Erythropoietin use
• Patients scheduled for ablation only
• Pregnant or lactating females

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Jarnagin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

US (1)