Stanworth, S.J., Estcourt, L.J., Powter, G., Kahan, B.C., Dyer, C., Choo, L., . . . TOPPS Investigators. (2013). A no-prophylaxis platelet-transfusion strategy for hematologic cancers. New England Journal of Medicine, 368(19), 17711780. 

DOI Link

Study Purpose

To determine whether or not having a prophylactic platelet policy was as safe and effective as giving prophylactic platelet transfusions

Intervention Characteristics/Basic Study Process

If their platelet count was less than 10, patients were randomly assigned to one of two groups. One group would receive prophylactic platelet transfusions on the same day of count less than 10. The other group would not receive prophylactic transfusion. The patients would continue the treatment arm for 30 days post-randomization. All patients were given platelet transfusion if bleeding occurred at World Health Organization (WHO) grade 2, before an invasive procedure, or at the discretion of the clinician. If WHO grade 3 or 4 bleeding occurred, patients were treated with platelets and no longer remained on the treatment arm but were still monitored per the protocol.

Sample Characteristics

  • N = 598
  • MEDIAN AGE = 55.5 years
  • MALES: 65%, FEMALES: 35%
  • KEY DISEASE CHARACTERISTICS: AML, ALL, CML, lymphoma, and multiple myeloma
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients who were receiving chemotherapy or stem cell transplants (70%) and were expected to be thrombocytopenic for at least five days.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: United Kingdom and Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care 

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Daily bleeding assessment forms were completed by trained staff when patients were inpatient.  
  • Bleeding diaries were kept by patients when in an outpatient setting.

Results

In relation to frequency of bleeding events of WHO grades 2, 3, or 4, the prophylactic group was superior to the no prophylactic group (p = 0.04). The number of days with bleeding events of WHO grades 2, 3, or 4 was higher in the no prophylactic group (p = 0.004). The length of time it took until a patient’s first bleeding event was shorter for the no prophylactic group (p = 0.02). Six patients in the no prophylactic group, as compared to one in the prophylactic group, had a WHO grade 3 or 4 bleeding event although the difference was not significant. The prophylactic group received more transfusions overall. Serious adverse events between the two groups were not significant.

Conclusions

The results of this study support the need for prophylactic platelet transfusions policies at cancer centers to reduce bleeding, although the authors note that their study cannot validate what is safe or effective practice.

Limitations

  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable

Nursing Implications

Nurses need to become familiar with the WHO grading criteria for bleeding episodes in order to help educate patients on the bleeding risks of low platelet counts. Nurses also need to know the policy of their own institution about what platelet threshold is used for prophylaxis, if such a policy exists. For those nurses who treat hematologic malignancies and/or stem cell transplant patients, the results of this trial could be the basis for an internal PI project.