Sargant, N., Roy, A., Simpson, S., Chandrakumaran, K., Alves, S., Coakes, J., . . . Moran, B. (2016). A protocol for management of blood loss in surgical treatment of peritoneal malignancy by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Transfusion Medicine, 26, 118–122. 

To determine if tranexamic acid and cryoprecipitate led to a reduction in blood loss and red cell transfusions in patients with peritoneal malignancies having surgery, and to see if the effect of the change in practice would lead to change in coagulation parameters or incidences of thrombosis

For the group in 2011, the standard protocol for cytoreductive surgery with hyperthermic intraperitoneal peroperative chemotherapy included using fresh frozen plasma (FFP) pre-emptively two hours into surgery, as well as for significant blood loss guided by laboratory values. Red blood cells, platelets, and cryoprecipitate were also transfused per laboratory values, per protocol. Following the CRASH-2 study, in 2013, a new protocol was devised to administer tranexamic acid at the beginning of surgery, with a repeated dose four hours into the procedure. If hemorrhage starts before 2 L of blood loss, cryoprecipitate is given with pre- and post-coagulation laboratory values. Laboratory tests were conducted throughout the surgery with intervention as appropriate.

• N = 201 
• AGE = 55 years
• MALES: 35%, FEMALES: 65%
• CURRENT TREATMENT: Chemotherapy, surgery
• KEY DISEASE CHARACTERISTICS: Peritoneal malignancy treated with cytoreductive surgery combined with hyperthermic intraperitoneal peroperative chemotherapy

• SITE: Single site  
• SETTING TYPE: Inpatient     
• LOCATION: United Kingdom

PHASE OF CARE: Active antitumor treatment

Prospective trial with a matched historical comparison group

• Two-tailed student t test using Excel
• P < 0.05 was significant. 
• The outcomes were measured by evaluating the fibrinogen, hemoglobin, prothrombin time, activated partial thromboplastin time, and platelets before and during the surgery.

The new protocol, using tranexamic acid, led to maintained average fibrinogen levels, a statistically significant increase in hemoglobin levels during and just following surgery, and a statistically significant reduction in blood loss. No significant reduction in FFP was observed and no difference in deep vein thrombosis existed in the two groups.

The patients given tranexamic acid and cryoprecipitate during cytoreductive surgery had higher fibrinogen levels and a decrease in blood loss—higher hemoglobin levels and fewer red cell transfusions. No higher arterial or venous thrombosis were observed in this group compared to the prior group.

• Risk of bias (no control group)            
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Measurement/methods not well described                  
• Measurement validity/reliability questionable
• Findings not generalizable
• Data samples from two different time periods, with changes in practice and issues of data; new protocol gives clearer direction to the team caring for patient 
• Because the newer protocol added tranexamic acid and cryoprecipitate together, it is unclear how they determined which was effective.

Nurses caring for patients with peritoneal cancer undergoing cytoreductive surgery and hyperthermic intraperitoneal peroperative chemotherapy should be aware of tranexamic acid and cryoprecipitate use to reduce blood loss.