Goldhaber 1996.

Study characteristics
Methods	Randomised controlled trial to assess efficacy and safety of rUK compared to heparin alone September 1992 to April 1994 361 screened, total randomised: 17 Allocation on 1:1 basis on morning of treatment Open labelled study Written informed consent
Participants	Country: USA Participants: 17 Symptoms of DVT < 14 days Age: > 18 years Sex: Male and female Inclusion criteria: DVT diagnosed by ultrasonography or venography for proximal lower extremity (popliteal,femoral, iliac veins with or without calf vein thrombosis) or MRI for upper extremity (brachial, axillary, subclavian, internal jugular veins) Exclusion criteria: stroke, intracranial disease or trauma, major chronic bleeding, major GI bleeding within one year, major urological bleeding 1 month, trauma or major surgery at non‐compressible site within 14 days, hypertension > 180/110 mmHg, haematocrit < 25% or platelet count < 100,000/mm3, pregnancy, nursing mothers, occult blood in stool, gross haematuria
Interventions	Recombinant urokinase group: 3 bolus infusions of 250,000 U in 5 mins via peripheral vein followed by continuous infusion of 750,000 U over 25 mins and 8 hours after initial dose. Final dose 24 hours after initial dose. Heparin administered 12 hours after first rUK dose for 12 hours until final rUK dose. Three hours after final rUK hep resumed to maintain activated PPT time of 60 to 80 seconds. Warfarin started the same evening to maintain INR of 2 to 3 Heparin group: initial bolus of 5000 to 10,000 U if they were not already receiving IV hep, then continuous infusion adjusted to maintain activated PPT time of 60 to 80 seconds. First dose of warfarin given within 24 hours of randomisation, target INR was 2 to 3
Outcomes	Clot lysis, venous flow, blood count and bleeding complications, fibrinogen levels
Funding	"Supported, in part, by a grant from Abbott Laboratories. Dr. Goldhaber receives support from the National Heart, Lung and Blood Institute Academic Award in Systemic and Vascular Medicine (HL 02663)."
Declaration of interests	‐
Notes	1 patient in each group had upper extremity DVT UK group had longer duration of symptoms (6 days versus 3 days)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation method not described
Allocation concealment (selection bias)	Unclear risk	Open label
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No details given but judged low risk as outcome assessment well described
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"...images compared and assessed by vascular panel blinded to randomization assignment and time point of image"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All data reported
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	None