Deep vein thrombosis landmark trials in treatment: Difference between revisions
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==Landmark Clinical Trials== | ==Landmark Clinical Trials== | ||
===Trials assessing treatment=== | ===Trials assessing treatment=== | ||
===Trial comparing Low-molecular-weight Heparin With Unfractionated Heparin=== | |||
1. Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis. (1990) <ref name="pmid1964751">{{cite journal |author=Bratt G, Aberg W, Johansson M, Törnebohm E, Granqvist S, Lockner D |title=Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT) |journal=Thromb. Haemost. |volume=64 |issue=4 |pages=506–10 |year=1990 |month=December |pmid=1964751 |doi= |url= |accessdate=2012-05-03}}</ref> | |||
* '''Patient enrollment:''' 119 patients | |||
*''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | |||
*''' Result:''' Repeat phlebography after 5-7 days showed improvement in 34/45 patients (76%) in the Fragmin group and in 30/49 patients (61%) in the SH group and progress in 2/45 (4%) and 3/49 (6%), respectively. The mean Marder scores decreased from 18.7 +/- 12.1 to 15.7 +/- 12.7 in the Fragmin group and from 16.9 +/- 12.0 to 14.4 +/- 11.8 in the SH group (ns). Two patients in the SH group and none in the Fragmin group had major bleedings. After 22 +/- 7 months follow up 6 rethromboses had occurred in the SH group and 4 in the Fragmin group. Postthrombotic signs and symptoms were similar in both groups. | |||
*''' Conclusion:''' Two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg. | |||
2. A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. (1991) <ref name="pmid1646490">{{cite journal |author= |title=A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. A collaborative European multicentre study |journal=Thromb. Haemost. |volume=65 |issue=3 |pages=251–6 |year=1991 |month=March |pmid=1646490 |doi= |url= |accessdate=2012-05-02}}</ref> | |||
A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. (1991) <ref name="pmid1646490">{{cite journal |author= |title=A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. A collaborative European multicentre study |journal=Thromb. Haemost. |volume=65 |issue=3 |pages=251–6 |year=1991 |month=March |pmid=1646490 |doi= |url= |accessdate=2012-05-02}}</ref> | |||
* '''Patient enrollment:''' 166 patients | * '''Patient enrollment:''' 166 patients | ||
*''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | *''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | ||
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor-In-Chief: Ujjwal Rastogi, MBBS [2]
Landmark Clinical Trials
Trials assessing treatment
Trial comparing Low-molecular-weight Heparin With Unfractionated Heparin
1. Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis. (1990) [1]
- Patient enrollment: 119 patients
- Purpose: To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis .
- Result: Repeat phlebography after 5-7 days showed improvement in 34/45 patients (76%) in the Fragmin group and in 30/49 patients (61%) in the SH group and progress in 2/45 (4%) and 3/49 (6%), respectively. The mean Marder scores decreased from 18.7 +/- 12.1 to 15.7 +/- 12.7 in the Fragmin group and from 16.9 +/- 12.0 to 14.4 +/- 11.8 in the SH group (ns). Two patients in the SH group and none in the Fragmin group had major bleedings. After 22 +/- 7 months follow up 6 rethromboses had occurred in the SH group and 4 in the Fragmin group. Postthrombotic signs and symptoms were similar in both groups.
- Conclusion: Two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg.
2. A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. (1991) [2]
- Patient enrollment: 166 patients
- Purpose: To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis .
- Result: Both "therapeutic efficacy" and "intention to-treat" analyses showed that subcutaneous CY 216 in fixed doses based only on body weight was more effective on the Arnesen and Marder phlebographic scores than continuous i.v. standard heparin with daily dose adjustment according to results of coagulation tests. There was no increase in the risks of pulmonary embolism, haemorrhage or clot extension.
References
- ↑ Bratt G, Aberg W, Johansson M, Törnebohm E, Granqvist S, Lockner D (1990). "Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT)". Thromb. Haemost. 64 (4): 506–10. PMID 1964751. Unknown parameter
|month=ignored (help);|access-date=requires|url=(help) - ↑ "A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. A collaborative European multicentre study". Thromb. Haemost. 65 (3): 251–6. 1991. PMID 1646490. Unknown parameter
|month=ignored (help);|access-date=requires|url=(help)