Verhaeghe 1989.
| Study characteristics | ||
| Methods | Allocation: random Double blind Exclusions after randomisation: nil Losses to follow‐up: nil |
|
| Participants | Country: France, Belgium, Switzerland Participants: 21 (in randomised phase only) Age: 22 to 74 years Sex: Male and female Inclusion criteria: hospitalised patients with DVT of popliteal or more proximal veins of the lower leg, confirmed by venography duration < 10 days Exclusion criteria: pregnancy; major surgery < 72 hours; stroke < 6 months; head trauma < 1 month; diastolic BP > 120 mmHg; renal/hepatic disease; peptic ulcer; bleeding dysfunction; contraindication to heparin |
|
| Interventions | Treatment: (2 groups) IV tPA 100 mg on day 1, 50 mg tPA on day 2. 10% of dose given as bolus IV tPA 50 mg on day 1, repeated on day 2. 10% of dose given as bolus Control: identical placebo infusion as above Co‐treatment: heparin 5000 U IV bolus then continuous infusion of 1000 U per hour for up to 72 hours |
|
| Outcomes | 72 hours: clot lysis; bleeding | |
| Funding | Not reported | |
| Declaration of interests | Not reported | |
| Notes | Included initial open label phase in some results (11 additional patients) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly allotted" not described further |
| Allocation concealment (selection bias) | Unclear risk | Not clearly described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blind" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Two radiologists interpreted all films without knowing the drug administered or whether the venography was before or after trial treatment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "No protocol violations" |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None |
APG: air plethysmography BP: blood pressure CDT: catheter‐directed thrombolysis CNS: central nervous system CVA: cerebrovascular accident DVT: deep vein thrombosis ECS: elastic compression stocking GI: gastrointestinal GU: genitourinary hep: heparin IM: intramuscular INR: international normalized ratio IU: international unit IV: intravenous LMWH: low molecular weight heparin PE: pulmonary embolism RCT: randomised controlled trial rt‐PA: recombinant tissue plasminogen activator strep: streptokinase sc: subcutaneous TB: tuberculosis PCDT: percutaneous catheter directed thrombolysis PMT: pharmacomechanical thrombolysis PTS: post thrombotic syndrome QoL: quality of life tPA: tissue plasminogen activator U: unit UFH: unfractionated heparin VEINES‐QOL: Venous Insufficiency Epidemiological and Economic Study Quality of Life VTE: venous thromboembolism