Protocol - Thromboprophylaxis
Description
This protocol from the Prophylactic Anticoagulation and central Venous access device-related thromboembolism In adult Sickle cell patients (PAVIS) clinical trial captures whether a participant has had thromboprophylaxis along with the type, dose, and any additional information describing it.
Specific Instructions
The Sickle Cell Disease Working Group recommends that investigators also consider these related protocols: Thrombosis - Catheter-related and Thrombosis - Venous, non-catheter-related. They also suggest that investigators capture the start and stop dates of prophylaxis as well as the trimester.
Availability
This protocol is freely available; permission not required for use.
Protocol
Thrombophrophylaxis
[ ] Thromboprophylaxis (Prophylactic Anticoagulation)Type: ________________________________
Dose: ________________________________
Description:
____________________________________________________
Personnel and Training Required
Personnel should be trained in medical record abstraction.
Equipment Needs
None
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | No |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Medical record abstraction
Lifestage
Child, Adolescent, Adult, Pregnancy
Participants
Children and adults with sickle cell disease
Selection Rationale
These questions from the Prophylactic Anticoagulation and central Venous access device-related thromboembolism In adult Sickle cell patients (PAVIS) clinical trial have been used in participants with sickle cell disease and are straightforward to either collect from the participant or abstract from the medical record.
Language
English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| caDSR Form | Px890101 Thromboprophylaxis | 15038307 | caDSR Form |
Derived Variables
None
Process and Review
Not Applicable
Protocol Name from Source
Prophylactic Anticoagulation and central Venous access device-related thromboembolism In adult Sickle cell patients (PAVIS)
Source
Forté, S., De Luna, G., Abdulrehman, J., Fadiga, N., Pestrin, O., Pham Hung dAlexandry dOrengiani, A. L., Aneke, J. C., Guillet, H., Budhram, D., Habibi, A., Ward, R., Bartolucci, P., & Kuo, K. H. M. (2022). Thromboprophylaxis Reduced Venous Thromboembolism in Sickle Cell Patients with Central Venous Access Devices: A Retrospective Cohort Study. Journal of clinical medicine, 11(5), 1193. https://doi.org/10.3390/jcm11051193
General References
Seaman, C. D., Yabes, J., Li, J., Moore, C. G., & Ragni, M. V. (2014). Venous thromboembolism in pregnant women with sickle cell disease: a retrospective database analysis. Thrombosis research, 134(6), 1249?1252. https://doi.org/10.1016/j.thromres.2014.09.037
Protocol ID
890101
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX890101_Thromboprophylaxis | ||||
| PX890101010000 | Thromboprophylaxis (Prophylactic Anticoagulation) | N/A | ||
| PX890101_Thromboprophylaxis_Description | ||||
| PX890101020000 | more | N/A | ||
| PX890101_Thromboprophylaxis_Dose | ||||
| PX890101010200 | Dose: ________________________________ | N/A | ||
| PX890101_Thromboprophylaxis_Type | ||||
| PX890101010100 | Type: ________________________________ | N/A | ||