Wandt, H., Schaefer-Eckart, K., Wendelin, K., Pilz, B., Wilhelm, M., Thalheimer, M., . . . Study Alliance Leukemia. (2012). Therapeutic platelet transfusion versus routine prophylactic transfusion in patients with haematological malignancies: An open-label, multicentre, randomised study. Lancet, 380, 1309–1316. 

To determine the effectiveness of the therapeutic transfusion strategy (bleeding occurred) versus the prophylactic strategy of platelet count of 10 x10⁹ at the morning blood draw in two defined groups

The primary end point of the study was to evaluate two groups of patients: patients with acute myeloid leukemia (AML) (group A, n = 190) versus patients who had received an autologous transplantation (group B, n = 201), comparing prophylactic platelet transfusion to therapeutic platelet transfusion. Group A consisted of a prophylactic group (n = 96) and a therapeutic group (n = 94). Group B also consisted of a prophylactic group (n = 98) and a therapeutic group (n = 94). Those in group A assigned to the prophylactic transfusion protocol were given one unit of platelets when the morning count was 10x10⁹ or lower one day after the end of induction therapy or consolidation. The protocol started on the day of stem cell transplantation in group B. The therapeutic groups received a transfusion only when a grade 2 or higher bleeding episode occurred. If bleeding continued, next steps, including further transfusions, were decided by the treating provider.

• N = 391   
• AGE = Group A: 16–80 years, Group B: 16–68 years
• MALES: 216, FEMALES: 175
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: AML or autologous peripheral stem cell transplantation for hematologic cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded from Group B if they had pulmonary or cerebral lesions. Patients who were refractory to platelets or had a previous major bleed or plasmatic coagulopathy were also excluded.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Germany

PHASE OF CARE: Active antitumor treatment

Multicenter, open-label randomized trial of patients with hematologic malignancies

In the prophylactic group, the morning platelet level was the determining factor to transfuse or not. In the therapeutic group, platelets were administered if a patient's bleeding was defined as a grade 2 or higher according to the World Health Organization criteria.

A significant result of p < 0.0001 in the reduction of platelets transfused in the therapeutic group was noted. The therapeutic group had a higher risk of grade 2 bleeding, which consisted mainly of petechial bleeding or purpura of the skin. The group with AML showed a significant result of p < 0.0001 in a grade 4 bleeding risk of 37% compared to the transplantation group of 18%.

This study revealed that the therapeutic strategy for patients receiving autologous stem cell transplantation would be safe and could become the standard of care with platelet transfusion limitation. The standard of care for patients with AML should remain the standard with prophylactic platelet transfusion because of the risk for increased bleeding.

There was only a 78% protocol compliance rate on the therapeutic group. The study was not powered to prove a significant difference in grade 4 bleeding events or lethal events.

Therapeutic platelet transfusions for patients receiving transplanations could become standard practice, given the hardship to maintain a continued platelet inventory, and decrease the risk of alloimmunization. Nurses need to remain vigilant in assessing and monitoring for increased bleeding. Education would be a necessity to ensure that early identification of potential bleeding is assessed.