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. 2022 Aug 20;62(10):2117–2136. doi: 10.1111/trf.17064

TABLE 1.

Trial characteristics of the included trials

Author, year Country centers setting Inclusion criteria Exclusion criteria Randomized, n (P/no P) Trial outcomes Follow‐up
Assir et al., 2013

Pakistan

1

Dengue HDU

Adults ≥ 14 years, dengue fever or dengue hemorrhagic fever, platelet counts < 30 × 109/L, no or mild bleeding (WHO grade 1 or 2) Other causes of thrombocytopenia, chronic ailments, history of platelet transfusion, severe bleeding (WHO grade 3 or 4) 48 a (21/24)
Primary:
  • Post‐transfusion platelet increments at 1 h (for the treatment group) and at 24 h and 72 h for both groups
Secondary:
  • Progression to severe bleeding (WHO grade 3 and 4)
  • Any new onset bleeding
  • Time to cessation of bleeding
  • Adverse events including death
72 h for the primary outcomes. Follow‐up for secondary outcomes unclear.
Grossman et al., 1980

Canada

1

Hospital ward

Patients with amegakaryocytic thrombocytopenia, platelet counts less than 50 × 109/L Refractory to platelet transfusions, not candidate for aggressive therapy, thrombocytopenia not expected to last for more than 7 days 100 (49/51)

Primary: Not specified

Secondary:
  • Mild and severe bleeding episodes
  • Number of platelet transfusions received
  • Platelet increments 1 h post transfusion
  • Incidence of platelet refractoriness (alloimmunization)
  • Mortality due to bleeding
Unclear. Patients were followed throughout their initial hospital stay and all subsequent admissions, (mean length of follow‐up was 42.7 days in the P‐group and 41.6 days in the no P‐group).
Lye et al., 2017

Singapore, Malaysia

5

Hospital ward b

Patients ≥ 21 years, probable or confirmed dengue (WHO 1997 or 2009 criteria), platelet count ≤20 × 109/L Platelet count > 20 × 109/L, signs of clinical bleeding, pregnancy, lactating women, history of severe reactions to blood product transfusion, prior platelet transfusion within the same illness episode, patients likely to die within 48 h, history of peptic ulcer within 3 months, anticoagulants' use within 4 weeks, chronic liver disease, chronic renal failure or dialysis, active hematological or autoimmune disease, non‐availability of platelet supply from local blood bank, consent unobtainable 372 (188/184)
Primary:
  • Clinical bleeding (excluding petechiae)
Secondary:
  • Rate of change of platelet count at 1 h, 12 h and 24 h post transfusion (transfusion group only)
  • Median time to sustained platelet count >50 × 109/L
  • Clinical bleeding excluding petechia within 21 days of randomization
  • Plasma leakage
  • Dengue hemorrhagic fever or dengue shock
  • Admission to intensive care unit
  • Death
  • Secondary bacterial infection
  • Median length of hospital stay
  • Adverse events from platelet transfusion
  • Severe bleeding
21 days
Murphy et al., 1982

USA

1

Hospital ward b

Children with previously untreated acute leukemia Not reported 56 (35/21)

Primary: Not specified

Secondary:
  • Number, dates, and durations of serious bleeding episodes
  • Number of days in which bleeding was present
  • Platelet transfusion requirements within the first 10 months of follow‐up
Unclear. Patients were followed from study entry until death or study closure (mean length of follow‐up was 19.9 months in the P‐group and 20.4 in the no P‐group).
Sintnicolaas et al., 1981

Netherlands

1 b

Hospital ward b

Patients with acute leukemia and severe thrombocytopenia Not reported 12 c (?/?)

Primary: Not specified

Secondary:
  • ‐Serological studies
  • Morbidity
  • Death due to bleeding
  • Refractory to random donor platelets
Unclear
Solomon et al., 1978

USA

1 b

Hospital ward b

Patients with previously untreated non‐lymphoblastic acute leukemia Promyelocytic leukemia 31 (19/12)

Primary: Not specified

Secondary:
  • Deaths (per chemotherapy course)
  • Deaths due to bleeding (per chemotherapy course)
  • Transfusion requirements (per chemotherapy course)
  • Complete remission rates
  • Complete and partial remission rates
Within 1 month of chemotherapy course
Stanworth et al., 2013

United Kingdom, Australia

14

Hospital ward

Patients ≥ 16 years, undergoing chemotherapy or stem‐cell transplantation to treat a hematological cancer, platelet count < 50 × 109/L or expected to be so for at least 5 days, able to comply with treatment and monitoring Previous WHO grade 3 or 4 bleeding, WHO grade 2 bleeding during current admission, inherited hemostatic or thrombotic disorder, requirement for therapeutic doses of anticoagulant agents, acute promyelocytic leukemia, known HLA antibodies, pregnancy, prior randomization into the trial 600 (299/301)
Primary:
  • Proportion of patients with a WHO Grade 2, 3, or 4 bleeds
Secondary:
  • Proportion of patients with a WHO Grade 3 or 4 bleed
  • All cause mortality
  • Time to first WHO Grade 2, 3 or 4 bleeds
  • The rate of Grade 2, 3, or 4 bleeds
  • Proportion of patients who receive at least one platelet transfusion
  • Number of platelet transfusions
  • Number of platelet units transfused
  • Total number of red blood cell transfusions
  • Total number of red blood cell units transfused
  • Time from randomization to recovery of thrombocytopenia
  • Number of days with platelet count less than 20 × 109/L
  • Number of days in hospital
30 days
Wandt et al., 2012

Germany

8

Hospital ward

Patients 16–80 years, undergoing intensive chemotherapy for acute myeloid leukemia or autologous haemopoietic stem‐cell transplantation for hematological cancers Refractory to platelet transfusions, previous major bleeding, plasmatic coagulopathy, pulmonary or cerebral lesions (stem‐cell transplantations only) 396 (197/199)
Primary:
  • Number of platelet transfusions given during a standardized observation time of 14 days per participant
Secondary:
  • Clinically relevant bleeding (WHO Grade ≥ 2) per treatment cycle
  • Percentage of days in which participants had bleeds of WHO Grade 2 or higher, dependent on morning platelet count
  • Days with platelet counts less than 20 × 109/L
  • Side‐effects of transfusions
  • Duration of hospital stay
  • Survival
  • Numbers of red blood cell transfusion
Unclear. The study was completed when the platelet count was self‐sustaining at more than 20 × 109 per L for 2 days or a maximum of 30 days, at hospital discharge, when treatment failure was diagnosed, at death, or at study withdrawal, which ever occurred first.
NCT03713489 (Ongoing)

China

1

Unclear

Patients 18–60 years, diagnosed with acute‐on‐chronic liver failure and chronic hepatitis B infection and ADP inhibition of ≥70%

Other causes of chronic live disease than chronic hepatitis B infection, previous decompensation, intracranial hemorrhage, use of anti‐platelet or anticoagulants therapy within 4 weeks, esophageal variceal bleeding within 1 week, platelet transfusion within 1 week,

malignant disease, pregnancy or breastfeeding, severe chronic extra‐hepatic disease. Considered not suitable for inclusion by researchers.

Estimated enrolment: 20
Primary:
  • 28‐day transplant free mortality
Secondary:
  • transplant‐free survival time
28 days for the primary outcome. Unclear for the secondary outcome.
van de Weerdt et al. (Ongoing)

Netherlands

11

Hospital ward/ICU

Adult (≥18 years) hematologic or ICU patients with thrombocytopenia (10–50 × 109/L) scheduled for emergency or elective insertion or replacement of a central line and an expectation of the inserted line to be in situ for at least 24 h Patients with a non‐correctable INR < 1.5, history of congenital or acquired coagulation factor deficiency or bleeding diathesis, treatment with double platelet‐aggregation inhibitors or therapeutic unfractionated heparin not discontinued at least 1 h prior to insertion Planned enrolment: 392 (196/196)
Primary:
  • Procedure‐related relevant bleeding, occurring within 24 h after the procedure
Secondary:
  • Platelet transfusion requirements within 24 h of CVC placement
  • Number of RBC transfusions within 24 h of CVC placement
  • WHO grade‐1 bleeding within 24 h of CVC placement
  • Hematoma size
  • Hemoglobin level at 1 h and 24 h after CVC placement
  • Platelet transfusion increment
  • HEME bleeding score
  • Allergic transfusion reaction within 24 h
  • Onset of acute lung injury within 48 h
  • Length of hospital stay
  • Mortality
  • Costs
28 days

Abbreviations: ADP, adenosine diphosphate; CVC, central venous catheter; HDU, high dependency unit; HEME, hemorrhage measurement; HLA, human leukocyte antigen; ICU, intensive care unit; INR, international normalized ratio; P, prophylaxis; RBC, red blood cells; WHO, World Health Organization.

a

Eighty‐seven patients were randomized but 39 patients had bleeding (WHO grade 1 or 2) at randomization and were ineligible for this review.

b

Assumption; not clearly reported.

c

Allocation to intervention groups not reported.