Date of study
N = 253 (121 male/132 female).
Mean age = 22.8 ± 4.5 years for tinzaparin group, 21.6 ± 3.8 years for control group.
Inclusion criteria of the trial
Exclusion criteria of the trial
Presence of medical or surgical contraindication to LMWH.
Low platelet counts (< 100,000/dl) or impaired haemostasis on admission in the form of INR > 1.4 or prolonged APTT > 5 seconds of the hospital normal range.
History of CVA.
Acute chest syndrome.
Anticoagulant therapy for other etiology.
Painful crises within the month before this admission.
Women on hormonal contraception.
History of painful crisis within the preceding month.
Other vascular complications of SCA (e.g. prior stroke, current aplasia, acute chest pain).
Withdrawals/losses to follow-up
Standard analgesia therapy: morphine 1 mg/h intravenous infusion and rehydration with normal saline.
|Outcomes||Outcomes of the trial (as reported)|
Clinical improvement and pain reported by the patient as zero degree on the NMS✴.
Therapy discontinuation after seven days regardless of the outcome,
Appearance of any complications including bleeding, heparin-induced thrombocytopenia or other complications✴.
Total period of hospitalisation in days✴.
Number of days on which the patient experienced the highest intensity on the NMS (Jaywant 2003
Duration of painful crisis in days✴.
✴Denotes outcomes pre-specified for this review.
|Risk of bias|
|Bias||Authors' judgement||Support for judgement|
|Random sequence generation (selection bias)||Unclear risk||Quote (page 393): "..Patients were randomized consecutively into either the study group.."|
Comment: Insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups.
|Allocation concealment (selection bias)||Unclear risk||The method used to conceal the allocation sequence, that is, to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment was not reported.|
Comment: Information was insufficient to permit a clear judgement.
|Blinding of participants and personnel (performance bias) |
|Unclear risk||Quote (page 393): "..double-blind.." and "All drug supplies were appropriately packaged, labeled, and kept in a locked, safe area under appropriate storage conditions with access limited to persons authorized by the investigator and those who [were] directly involved in the study."|
Comment: The report did not provide sufficient detail about the specific measures used to blind study participants and personnel from knowledge of which intervention a participant received, to permit a clear judgement.
|Blinding of outcome assessment (detection bias) |
|Unclear risk||Quote (page 393): "..double-blind.."|
Comment: The report did not provide sufficient detail about the specific measures used to blind study participants and personnel. It was unclear, therefore, whether the outcome measurement was likely to be influenced by the lack of blinding.
|Incomplete outcome data (attrition bias) |
|Low risk||No losses reported.|
Comment: We judged this as at low risk of bias.
|Selective reporting (reporting bias)||Low risk||The protocol for the study was not available, but the pre-specified outcomes and those mentioned in the methods section appear to have been reported.|
Comment: We judged this as at a low risk of bias.
|Other bias||High risk||One of the investigators is employed by Leo Pharmaceutical Products, Athens, Greece, the manufacturer of tinzaparin.|
The NMS scale for assessing pain severity is not a validated tool for pain assessment.
Comment: A potential risk of bias cannot be excluded.