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

PHASE3CompletedINTERVENTIONAL
Enrollment

372

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
PancreaticoduodenectomyHepatectomy
Interventions
PROCEDURE

Normovolemic Hemodilution (ANH)

For those patients randomized to ANH, the pre-calculated volume of blood will be withdrawn to a target hemoglobin of 8.0 - 8.5 g/dl (maximum of 3 L) using the formula VL=EBV x (HO-HF)/Hav, as above.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.

PROCEDURE

Standard of care

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.

Trial Locations (1)

10021

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00200148 - Acute Normovolemic Hemodilution Versus Standard Intraoperative Management in Patients Having Hepatic Resection and Pancreaticoduodenectomy | Biotech Hunter | Biotech Hunter