Acute Normovolemic Hemodilution Versus Standard Intraoperative Management in Patients Having Hepatic Resection and Pancreaticoduodenectomy

NCT00200148 | Completed Phase 3

• 1 other identifier: 04-004
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

With a major liver or pancreas operation, there is a chance that one will require a transfusion of blood products (either red blood cells or plasma). This may be necessary during the operation or a few days after surgery. The surgeons at Memorial Sloan-Kettering Cancer Center perform a very large number of liver or pancreas resections every year and have pioneered techniques that minimize bleeding during the operation. Even so, liver or pancreas operations such as the one that will be undergone carry a 50% chance of requiring a transfusion. A technique that might lower the need for transfusions is called acute normovolemic hemodilution (ANH). ANH was first introduced over twenty years ago and has been used in many types of operations, including liver or pancreas resection. The studies done on ANH at other hospitals suggest that it may help conserve blood. Researchers at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if ANH is better than the 'standard technique' that is currently used in all patients. The purpose of this study is to find out which of the two techniques is better. The purpose of the study is to see if ANH lowers the need for the transfusion of blood products during and after liver or pancreas resection. The second purpose of the study is to see how ANH changes the length of the operation, the length of time one spends in the hospital, and the complication rate after surgery. The researchers will also see if ANH requires any changes in the administration of anesthesia.

Conditions

Pancreaticoduodenectomy; Hepatectomy

Keywords

Pancreaticoduodenectomy; Hepatectomy; Major Hepatic resection; Acute Normovolemic Hemodilution

Outcome Measures

Primary Outcomes (1)

• To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management

  All patients will have their blood checked every 30 minutes during surgery

Secondary Outcomes (3)

• To determine if ANH reduces the requirement for allogeneic FFP transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management

  All patients will have their blood checked every 30 minutes during surgery

• To determine the impact of ANH on post-operative complications, length of hospital stay and operating time compared to standard intraoperative management

  Two weeks

• To assess the impact of ANH on low central venous pressure (CVP) anesthetic management during partial hepatectomy

  Continuous monitoring during surgery

Study Arms (2)

1

EXPERIMENTAL

For patients randomized to ANH

Procedure: Normovolemic Hemodilution (ANH)

2

ACTIVE COMPARATOR

standard intraoperative management

Procedure: Standard of care

Interventions

Normovolemic Hemodilution (ANH) PROCEDURE

For those patients randomized to ANH, the pre-calculated volume of blood will be withdrawn to a target hemoglobin of 8.0 - 8.5 g/dl (maximum of 3 L) using the formula VL=EBV x (HO-HF)/Hav, as above. The removed blood will be stored in a standard citrate-phosphate-dextrose buffer solution in blood storage bags in the operating room. During removal of blood, colloid and crystalloid solutions will be administered via peripheral intravenous lines in order to maintain euvolemia. For all patients, arterial blood will be sampled every 30 minutes during the resection for assessment of arterial blood gases/pH; Hgb levels will be measured every 30 minutes.For patients randomized to ANH, autologous blood will be re-infused in the reverse order from which it was removed, and allogeneic blood will given only after all autologous blood has been given.

1

Standard of care PROCEDURE

An 8.5 French central venous catheter and an arterial line will be placed in all patients. If the patient has a central line already in place, this may be used in place of the 8.5 French internal jugular catheter. Continuous monitoring of heart rate, blood pressure, ECG (II, V5), CVP, end tidal CO2, oxygen saturation, temperature and urine output will be performed for all patients.For all hepatic resections, standard low CVP anesthetic management will be employed.For all patients, arterial blood will be sampled every 30 minutes during the resection for assessment of arterial blood gases/pH; Hgb levels will be measured every 30 minutes.All patients will receive standard postoperative management. Routine laboratory studies, including comprehensive panel, CBC and coagulation profile, will be obtained daily in the post-operative period.

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).
• Pre-operative hemoglobin concentration \>= 11 mg/dl (males); \>= 10 mg/dl (females) within 14 days of registration.
• Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures or patients scheduled for pancreaticoduodenectomy

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 left ventricular (LV) function within 30 days of operation.
• A history of cerebrovascular disease.
• A history of congestive heart failure.
• A history of uncontrolled hypertension.
• A history of restrictive or obstructive pulmonary disease.
• A history of renal dysfunction (creatinine \[Cr\] \> 1.8).
• Abnormal coagulation parameters (International Normalized Ratio \[INR\] \> 1.5 not on Coumadin, or platelet count \< 100,000).
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Fischer M, Matsuo K, Gonen M, Grant F, Dematteo RP, D'Angelica MI, Mascarenhas J, Brennan MF, Allen PJ, Blumgart LH, Jarnagin WR. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg. 2010 Dec;252(6):952-8. doi: 10.1097/SLA.0b013e3181ff36b1.

  PMID: 21107104 DERIVED

• Jarnagin WR, Gonen M, Maithel SK, Fong Y, D'Angelica MI, Dematteo RP, Grant F, Wuest D, Kundu K, Blumgart LH, Fischer M. A prospective randomized trial of acute normovolemic hemodilution compared to standard intraoperative management in patients undergoing major hepatic resection. Ann Surg. 2008 Sep;248(3):360-9. doi: 10.1097/SLA.0b013e318184db08.

  PMID: 18791356 DERIVED

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William R. Jarnagin, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2004
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)